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510(k) K980732

3M CDI QUICK-CELLS WITH HEPARIN TREATMENT by 3M Healthcare — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1998
Date Received
February 25, 1998
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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