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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 K896085
Device Name SURGI-BRUSH
Applicant
Sparta Surgical Corp.
26602 Corporate Ave.
Hayward,  CA  94545
Applicant Contact CINDY WILSON
Correspondent
Sparta Surgical Corp.
26602 Corporate Ave.
Hayward,  CA  94545
Correspondent Contact CINDY WILSON
Regulation Number878.4800
Classification Product Code
GEC  
Date Received10/19/1989
Decision Date 11/08/1989
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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