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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K791859
Device Name TECNOL STIRRUPS STRAP
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 Number878.4950
Classification Product Code
BWN  
Date Received09/18/1979
Decision Date 10/04/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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