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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853623
Device Name CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N
Applicant
Co-Medical, Inc.
2240 Lee St.
Lakewood,  CO  80215
Applicant Contact DAVE GOTO
Correspondent
Co-Medical, Inc.
2240 Lee St.
Lakewood,  CO  80215
Correspondent Contact DAVE GOTO
Date Received08/29/1985
Decision Date 10/08/1985
Decision Substantially Equivalent (SESE)
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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