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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 K875129
Device Name STERI-CLENS
Applicant
ABSORBENT COTTON CO., INC.
P.O. BOX 268
368 FAIRVIEW AVENUE
HAMMONTON,  NJ  08037
Applicant Contact PATRICK J LAMB
Correspondent
ABSORBENT COTTON CO., INC.
P.O. BOX 268
368 FAIRVIEW AVENUE
HAMMONTON,  NJ  08037
Correspondent Contact PATRICK J LAMB
Regulation Number878.4800
Classification Product Code
GEC  
Date Received12/15/1987
Decision Date 02/18/1988
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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