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510(k) K020103

PRISMAFLO by Stihler Electronic GmbH — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2002
Date Received
January 11, 2002
Clearance Type
Abbreviated
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 Stihler Electronic GmbH

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  • K082758 — PRISMAFLO II (December 19, 2008)
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  • K991159 — PRISMATHERM II, ASTOLINE (September 3, 1999)
  • K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (September 2, 1999)

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