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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