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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K980937
Device Name NICORE MODEL ESP -1
Applicant
NICORE EQUIPMENT & LEASING, INC.
1625 K STREET, NW, SUITE 1000
WASHINGTON,  DC  20006 -1604
Applicant Contact MICHAEL G FARROW
Correspondent
NICORE EQUIPMENT & LEASING, INC.
1625 K STREET, NW, SUITE 1000
WASHINGTON,  DC  20006 -1604
Correspondent Contact MICHAEL G FARROW
Regulation Number870.5225
Classification Product Code
DRN  
Date Received03/12/1998
Decision Date 09/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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