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510(k) K884609

EURO-COLLINS SOLUTION SETS by Fresenius USA, Inc. — Product Code KDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1989
Date Received
November 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

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  • K121618 — BEL-GEN COLD STORAGE SOLUTION (June 14, 2013)
  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
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