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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 (other material) - daily
510(k) Number K011945
Device Name RIGID GAS PERMEABLE CONTACT LENS SOLUTION
Applicant
POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER,  NY  14692
Applicant Contact DEBRA L.B. KETCHUM
Correspondent
POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER,  NY  14692
Correspondent Contact DEBRA L.B. KETCHUM
Regulation Number886.5916
Classification Product Code
HQD  
Date Received06/21/2001
Decision Date 09/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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