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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 K920162
Device Name TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
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 Received01/14/1992
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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