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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K893702
Device Name TECNOL GAITERS PRODUCT NUMBER 47725-010
Applicant
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact LEONA HAMMEL
Correspondent
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact LEONA HAMMEL
Regulation Number878.4040
Classification Product Code
FXP  
Date Received05/18/1989
Decision Date 06/23/1989
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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