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510(k) K902588

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD by Gambro-Hospal, Inc. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1991
Date Received
June 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Gambro-Hospal, Inc.

  • K896068 — TIPSTOP(TM) (September 10, 1990)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)

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