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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dress, Surgical
510(k) Number K895667
Device Name STERILE SURGICAL GOWN
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 Number878.4040
Classification Product Code
FYE  
Date Received09/20/1989
Decision Date 10/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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