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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K960509
Device Name 18 GAUGE TRU-CUT BIOPSY NEEDLE
Applicant
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
BLDG. K
MCGAW PARK,  IL  60085
Applicant Contact SHARON RICHTER
Correspondent
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
BLDG. K
MCGAW PARK,  IL  60085
Correspondent Contact SHARON RICHTER
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/05/1996
Decision Date 04/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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