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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous, Biopsy
510(k) Number K925870
Device Name SPACER
Applicant
Bip USA, Inc.
727 Main St.
Niagara Falls,  NY  14301
Applicant Contact GARY HORNER
Correspondent
Bip USA, Inc.
727 Main St.
Niagara Falls,  NY  14301
Correspondent Contact GARY HORNER
Regulation Number878.4800
Classification Product Code
MJG  
Date Received11/19/1992
Decision Date 05/19/1993
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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