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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 K854232
Device Name PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
Applicant
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Applicant Contact LAWRENCE GETLIN
Correspondent
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Correspondent Contact LAWRENCE GETLIN
Regulation Number878.4800
Classification Product Code
GEC  
Date Received10/21/1985
Decision Date 12/10/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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