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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K852870
Device Name BARRIER SURGICAL GOWN
Applicant
Surgikos, Inc.
P.O. Box 130
Arlington,  TX  76010
Applicant Contact CHRISTAL O FISHER
Correspondent
Surgikos, Inc.
P.O. Box 130
Arlington,  TX  76010
Correspondent Contact CHRISTAL O FISHER
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/08/1985
Decision Date 07/23/1985
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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