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510(k) K844401

REPRO-MED SYSTEMS INFUSION DEVICE by Repro-Med Systems, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
November 13, 1984
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 Repro-Med Systems, Inc.

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  • K933652 — FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING (May 18, 1994)
  • K894299 — REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM (September 22, 1989)
  • K892529 — REPRO-MED NEONATE ASPIRATION SYSTEM (June 12, 1989)

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