FDA 510(k), K853126, BIO PACK MODEL 200

FDA 510(k), K853126, BIO PACK MODEL 200

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510(K) Number: K853126
Device Name: BIO PACK MODEL 200
Manufacturer: BIO MEDICUS, INC.
Device Classification Name: control, pump speed, cardiopulmonary bypass
Regulation Number: 870.4380
Classification Product Code: DWA
Date Received: 07/25/1985
Decision Date: 10/11/1985
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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