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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K885145
Device Name MEDSURG GREENE NEEDLE
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact THOMAS BONNER
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact THOMAS BONNER
Regulation Number878.4800
Classification Product Code
DWO  
Date Received12/15/1988
Decision Date 03/14/1989
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
Predetermined Change
Control Plan Authorized		 No
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