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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K896367
Device Name STERILE SURGICAL DRAPES AND SHEETS
Applicant
Clinitech, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact LOUIE F TURNER
Correspondent
Clinitech, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact LOUIE F TURNER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/06/1989
Decision Date 12/04/1989
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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