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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, soft lens products
510(k) Number K923437
Device Name BOSTON CLEANER II
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 Number886.5928
Classification Product Code
LPN  
Date Received07/13/1992
Decision Date 10/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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