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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 K915817
Device Name TECNOL FLUIDSHIELD INFECTION CONTROL MASK
Applicant
Tecnol Medical Products, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact RUTH L JONES
Correspondent
Tecnol Medical Products, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact RUTH L JONES
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/30/1991
Decision Date 01/27/1993
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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