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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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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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