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510(k) K080297

MEDRAD INTEGO PET INFUSION SYSTEM by Medrad, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2008
Date Received
February 4, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET (May 24, 2011)
  • K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRAT (June 23, 2010)

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