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510(k) K964967

BIOCOR 200 HIGH PERFORMANCEOXYGENATOR by Minntech Corp. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
December 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (March 8, 1999)

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