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510(k) K911577

HYPOTRANS MODEL 750 by Martin Mclane Medical — Product Code KDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1992
Date Received
April 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Transport, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances for product code KDK

  • K053169 — RM3 RENAL PRESERVATION SYSTEM (January 17, 2006)
  • K801899 — KEITHLEY LYMPHOCYTE DEPLETION CART (September 26, 1980)