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FDA 510(k) Application Details - K152115
Device Classification Name
Device, Counter-Pulsating, External
More FDA Info for this Device
510(K) Number
K152115
Device Name
Device, Counter-Pulsating, External
Applicant
Stage 2 Innovations
7811 Montrose Rd
Rockville, MD 20854 US
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Contact
Richard Kotz
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
07/29/2015
Decision Date
12/17/2015
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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