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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 K943177
Device Name BOSTON(R) 7 - 30(ENFLUFOCON A)
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 Received07/01/1994
Decision Date 08/25/1994
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
Recalls CDRH Recalls
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