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FDA 510(k) Application Details - K982640
Device Classification Name
Pump, Infusion
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510(K) Number
K982640
Device Name
Pump, Infusion
Applicant
MEDEX, INC.
3637 LACON RD.
HILLIARD, OH 43026 US
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Contact
CATHY CHENETSKI
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
07/29/1998
Decision Date
04/06/1999
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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