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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Hearing (Insert)
510(k) Number K915739
Device Name #903 SILAFLEX II
Applicant
Flents Products Co., Inc.
P.O. Box 2109
Norwalk,  CT  06852
Applicant Contact PETER C KOHN
Correspondent
Flents Products Co., Inc.
P.O. Box 2109
Norwalk,  CT  06852
Correspondent Contact PETER C KOHN
Classification Product Code
EWD  
Date Received12/16/1991
Decision Date 06/30/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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