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510(k) K973472

3M CDI H/S CUVETTES WITH HEPARON TREATMENT by 3M Healthcare — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1997
Date Received
September 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

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