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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 K000795
FOIA Releasable 510(k) K000795
Device Name RIGID GAS PERMEABLE CONTACT LENS
Applicant
POLYMER TECHNOLOGY
1400 N GOODMAN ST.
ROCHESTER,  NY  14692
Applicant Contact DEBRA L.B. KETCHUM
Correspondent
POLYMER TECHNOLOGY
1400 N GOODMAN ST.
ROCHESTER,  NY  14692
Correspondent Contact DEBRA L.B. KETCHUM
Regulation Number886.5916
Classification Product Code
HQD  
Date Received03/13/2000
Decision Date 05/26/2000
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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