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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K961662
Device Name ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
Applicant
Mariner Biomedical, Inc.
73 Faulkner Dr.
Guilford,  CT  06437
Applicant Contact RICHARD E GALARDY
Correspondent
Mariner Biomedical, Inc.
73 Faulkner Dr.
Guilford,  CT  06437
Correspondent Contact RICHARD E GALARDY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/30/1996
Decision Date 06/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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