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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Binder, Abdominal
510(k) Number K760772
Device Name DISPOSABLE ABDOMINAL BINDER
Applicant
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
Correspondent
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
Regulation Number880.5160
Classification Product Code
FSD  
Date Received10/04/1976
Decision Date 11/03/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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