FDA 510(k) Application Details - K973472

Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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510(K) Number K973472
Device Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE
1311 VALENCIA AVE.
TUSTIN, CA 92780 US
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Contact DIANA RHEA
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Regulation Number 870.4330

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Classification Product Code DRY
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Date Received 09/12/1997
Decision Date 12/08/1997
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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