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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 K782172
Device Name BRUSH/SPONGE, DISPOSABLE
Applicant
DEXIDE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEXIDE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GEC  
Date Received12/29/1978
Decision Date 01/10/1979
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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