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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 K870258
Device Name BIOSCRUB SURGICAL SCRUB BRUSH
Applicant
K. W. GRIFFEN CO.
C/O CORNELIA DAMSKY, INC.
56 WESTCOTT ROAD
STAMFORD,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
K. W. GRIFFEN CO.
C/O CORNELIA DAMSKY, INC.
56 WESTCOTT ROAD
STAMFORD,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Regulation Number878.4800
Classification Product Code
GEC  
Date Received01/23/1987
Decision Date 02/24/1987
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
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