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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
Predetermined Change
Control Plan Authorized		 No
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