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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K874608
Device Name TECNOL FLUID SHIELD SURGICAL MASK
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
FXX  
Date Received11/09/1987
Decision Date 12/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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