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510(k) K941151

STRATOFUSE PCA II INFUSER by Infusion Technology Intl. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1994
Date Received
March 11, 1994
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

Other clearances by Infusion Technology Intl.

  • K943591 — VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM (June 28, 1995)
  • K935461 — VECTOR AMBULATORY DRUG DELIVERY SYSTEM (April 28, 1994)

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