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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 K911907
Device Name FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
Applicant
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact RUTH L JONES
Correspondent
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact RUTH L JONES
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/30/1991
Decision Date 07/08/1991
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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