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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name brush, biopsy, general & plastic surgery
510(k) Number K854003
Device Name STERILE SOFT TISSUE BIOPSY NEEDLE
Applicant
CO-MEDICAL, INC.
2240 LEE ST.
LAKEWOOD,  CO  80215
Applicant Contact GARY BRUNNER
Correspondent
CO-MEDICAL, INC.
2240 LEE ST.
LAKEWOOD,  CO  80215
Correspondent Contact GARY BRUNNER
Regulation Number878.4800
Classification Product Code
GEE  
Date Received09/30/1985
Decision Date 10/18/1985
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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