FDA 510(k) Application Details - K944866

Device Classification Name Set, Perfusion, Kidney, Disposable

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510(K) Number K944866
Device Name Set, Perfusion, Kidney, Disposable
Applicant THE DUPONT MERCK PHARMACEUTICAL CO.
EXPERIMENTAL STATION BLDG. 353
WILMINGTON, DE 19880-0353 US
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Contact JAMES L GASKILL
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Regulation Number 876.5880

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Classification Product Code KDL
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Date Received 10/03/1994
Decision Date 04/22/1996
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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