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FDA 510(k) Application Details - K011046
Device Classification Name
Compressor, Cardiac, External
More FDA Info for this Device
510(K) Number
K011046
Device Name
Compressor, Cardiac, External
Applicant
REVIVANT CORP.
775 PALOMAR
SUNNYVALE, CA 94085 US
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Contact
BOB KATZ
Other 510(k) Applications for this Contact
Regulation Number
870.5200
More FDA Info for this Regulation Number
Classification Product Code
DRM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2001
Decision Date
10/25/2001
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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