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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Scrub, Operating-Room
510(k) Number K874653
Device Name STERILE SURGICAL SCRUB BRUSH
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 Number878.4800
Classification Product Code
GEC  
Date Received11/13/1987
Decision Date 12/30/1987
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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