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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Surgical
510(k) Number K873830
Device Name TECNOL SURGEON'S CAP
Applicant
Tecnol New Jersey Wound Care, Inc.
7450 Whitehall St.
Fort Worth,  TX  76012
Applicant Contact DAVID ARCHER
Correspondent
Tecnol New Jersey Wound Care, Inc.
7450 Whitehall St.
Fort Worth,  TX  76012
Correspondent Contact DAVID ARCHER
Regulation Number878.4040
Classification Product Code
FYF  
Date Received09/21/1987
Decision Date 10/23/1987
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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