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FDA 510(k) Application Details - K972206
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
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510(K) Number
K972206
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON, KY 40514-1268 US
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Contact
KAELYN HADLEY
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
KOC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/11/1997
Decision Date
11/26/1997
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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