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510(k) K851077

CARDIAC COOLING JACKET by Pat O. Daily — Product Code KRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
March 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

Other clearances by Pat O. Daily

  • K850083 — TISSUE TEMP PROBE (March 27, 1985)

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