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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, Occlusive
510(k) Number K884440
Device Name TECNOL VARIABLE TENSION BANDAGE
Applicant
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number878.4020
Classification Product Code
NAD  
Date Received10/21/1988
Decision Date 01/17/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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