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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 K875033
Device Name STERILE SCRUBBY SCRUB BRUSH
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact DONNA PLANTE
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact DONNA PLANTE
Regulation Number878.4800
Classification Product Code
GEC  
Date Received12/07/1987
Decision Date 02/19/1988
Decision Substantially Equivalent - With Drug (SESD)
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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