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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 K896193
Device Name TECNOL LAZER(TM) SURGICAL MASK
Applicant
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/25/1989
Decision Date 02/27/1990
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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