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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Needle, Surgical
510(k) Number K935457
Device Name LOCALIZATION WIRE OR MARKER - SURGICAL
Applicant
Bip USA, Inc.
Carborundum Center
Suite 480, 345 Third St.
Niagara Falls,  NY  14303
Applicant Contact GARY HORNER
Correspondent
Bip USA, Inc.
Carborundum Center
Suite 480, 345 Third St.
Niagara Falls,  NY  14303
Correspondent Contact GARY HORNER
Regulation Number878.4800
Classification Product Code
GDF  
Date Received11/12/1993
Decision Date 02/17/1994
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
Recalls CDRH Recalls
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