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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 K810655
Device Name DISPOSABLE SCRUB BRUSH
Applicant
Dexide, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dexide, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GEC  
Date Received03/03/1981
Decision Date 05/05/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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