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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name products, contact lens care, rigid gas permeable
510(k) Number K983836
Device Name RIGID GAS PERMEABLE CONTACT LENS SOLUTION
Applicant
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14692
Applicant Contact DEBRA L.B. KETCHUM
Correspondent
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14692
Correspondent Contact DEBRA L.B. KETCHUM
Regulation Number886.5918
Classification Product Code
MRC  
Date Received10/30/1998
Decision Date 02/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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