FDA 510(k), K896393, CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620

FDA 510(k), K896393, CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620

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510(K) Number: K896393
Device Name: CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
Manufacturer: DAILY MEDICAL, INC.
Device Classification Name: controller, temperature, cardiopulmonary bypass
Regulation Number: 870.4250
Classification Product Code: DWC
Date Received: 11/06/1989
Decision Date: 02/02/1990
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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