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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 K932137
Device Name FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
Applicant
TECNOL MEDICAL PRODUCTS, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
TECNOL MEDICAL PRODUCTS, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/27/1993
Decision Date 04/15/1994
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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