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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact, polymethylmethacrylate, diagnostic
510(k) Number K030054
Device Name DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
Applicant
FCI OPHTHALMICS, INC.
344 ANNABELLE POINT RD.
CENTERVILLE,  MA  02632 -2402
Applicant Contact HILLARD WELCH
Correspondent
FCI OPHTHALMICS, INC.
344 ANNABELLE POINT RD.
CENTERVILLE,  MA  02632 -2402
Correspondent Contact HILLARD WELCH
Regulation Number886.1385
Classification Product Code
HJK  
Subsequent Product Codes
HMX   HNN  
Date Received01/06/2003
Decision Date 02/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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