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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, absorbable, (scleral buckling methods)
510(k) Number K884362
Device Name LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
Applicant
BAUSCH & LOMB PHARMACEUTICAL, INC.
11300 49TH.STREET NORTH
CLEARWATER,  FL  34622
Applicant Contact H DUFFELL
Correspondent
BAUSCH & LOMB PHARMACEUTICAL, INC.
11300 49TH.STREET NORTH
CLEARWATER,  FL  34622
Correspondent Contact H DUFFELL
Regulation Number886.3300
Classification Product Code
HQJ  
Date Received10/20/1988
Decision Date 11/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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