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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K936226
Device Name SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07045
Applicant Contact JANE AYOYAGI
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07045
Correspondent Contact JANE AYOYAGI
Regulation Number878.4800
Classification Product Code
KDC  
Subsequent Product Code
GDF  
Date Received12/29/1993
Decision Date 03/07/1994
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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