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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 K002025
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 Received07/03/2000
Decision Date 10/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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