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Address: P.O. Box 465, Marshfield Hills, Massachusetts 02051, USA
www.fci-ophthalmics.com |
Send Inquiry |
Phone: +1-(781)-826-9060
FDA Registration: 1225124 Year Established: 1996
Annual Revenues: USD 1-5 Million
Quality: ISO 9002, CE Certified
Products: Conformers, Gold Weighted Eyelid Implants, Punctum Plugs (Punctal Plugs), Wright Needles, Evisceration Scoops, Titanium Plating Systems, ...
FCI Ophthalmics concentrates in ophthalmic surgical devices. Our products include retina, cataract, lid repair, orbital implants, lacrimal stents & tubes, and dry products. The orbital implant product
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Address: 24 Hua Mei Street, Taichung 403, Taiwan
Phone: +886-(4)-23716751
Products: Manual Beds (FDA Code:
FNJ), Alternating Pressure Air Flotation Mattress (FDA Code:
FNM), Air Flotation Mattress (FDA Code:
FNM), Ptosis Crutch (FDA Code:
HJZ), Safety Walk Cane (FDA Code:
KHY), Wheelchair Commode Attachment (FDA Code:
INB), ...
King Galloma Corp. is a manufacturer of air mattresses, bed side rails, cane sticks, safety walkers and accessories.
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Address: 8th Fl., Sk Building , 16-4 Sungsudong-1 G, Sungdong-Gu 133-110, Korea, Republic Of
www.hansbiomed.com |
Send Inquiry |
Phone: +82-(2)-466-2266
FDA Registration: 3003828812
Products: Scar Treatment Kits, Herbal Aromatherapy Heating Cooling Pack, Nasal Splints (FDA Code:
EPP), Breast Implants, Silicone Gel Sheets, Surgical Wire (FDA Code:
LRN), ...
Hans Biomed Corp. deals with human tissue engineering. We offer products for plastic surgery, cosmetics, dentistry, orthopedics and burns. Our plastic surgery products include SureDerm ™ and Sca
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FDA Code / Regulation: HJZ / 886.5600 A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.