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FDA 510(k) Application Details - K972213
Device Classification Name
Flowmeter, Blood, Cardiovascular
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510(K) Number
K972213
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
ALAN S. LEE
2121 W BEACON AVE.
ANAHEIM, CA 92804 US
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Contact
ALAN S LEE
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Regulation Number
870.2100
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Classification Product Code
DPW
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Date Received
06/12/1997
Decision Date
03/13/1998
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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