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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K023138
Device Name HYDROFERA BACTERIOSTATIC WOUND DRESSING
Applicant
Hydrofera, LLC
322 Main St., Suite 1101
Willimantic,  CT  06226
Applicant Contact HEATHER S BOND
Correspondent
Hydrofera, LLC
322 Main St., Suite 1101
Willimantic,  CT  06226
Correspondent Contact HEATHER S BOND
Classification Product Code
FRO  
Date Received09/20/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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