FDA 510(k) Application Details - K962907

Device Classification Name Instrument, Biopsy

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510(K) Number K962907
Device Name Instrument, Biopsy
Applicant BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
BLDG. K
MCGAW PARK, IL 60085 US
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Contact SHARON ROBBINS
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 07/25/1996
Decision Date 10/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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