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FDA 510(k) Application Details - K992857
Device Classification Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K992857
Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Applicant
ROCKY MOUNTAIN RESEARCH, INC.
825 NORTH 300 WEST, SUITE 500
SALT LAKE CITY, UT 84103 US
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Contact
ROBERT W GRIFFITHS
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Regulation Number
870.4340
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Classification Product Code
DTW
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More FDA Info for this Product Code
Date Received
08/25/1999
Decision Date
11/10/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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