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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K844702
Device Name GAUZE ASORBABLE
Applicant
Medicon, Inc.
143 New Canaan Ave.
Norwalk,  CT  06850
Applicant Contact JAMES C NICHOLAS
Correspondent
Medicon, Inc.
143 New Canaan Ave.
Norwalk,  CT  06850
Correspondent Contact JAMES C NICHOLAS
Classification Product Code
EFQ  
Date Received12/03/1984
Decision Date 04/01/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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