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FDA 510(k) Application Details - K980937
Device Classification Name
Device, Counter-Pulsating, External
More FDA Info for this Device
510(K) Number
K980937
Device Name
Device, Counter-Pulsating, External
Applicant
NICORE EQUIPMENT & LEASING, INC.
1625 K STREET, NW, SUITE 1000
WASHINGTON, DC 20006-1604 US
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Contact
MICHAEL G FARROW
Other 510(k) Applications for this Contact
Regulation Number
870.5225
More FDA Info for this Regulation Number
Classification Product Code
DRN
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More FDA Info for this Product Code
Date Received
03/12/1998
Decision Date
09/15/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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