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510(k) K943692

SMART DOSE(TM) by River Medical, Inc. — Product Code FRN

Clearance Details

Decision
ST ()
Decision Date
April 28, 1995
Date Received
July 28, 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 River Medical, Inc.

  • K023174 — DISPOSABLE TEMPORARY PACING WIRE (June 11, 2003)
  • K944351 — SMARTDOSE IV PREFILLED INFUSION CONTAINER (November 15, 1995)
  • K944352 — SMARTDOSE III INFUSION CONTAINER (November 15, 1995)
  • K945298 — SMARTFLOW I ADMINISTRATION SET (June 14, 1995)
  • K932895 — RIVER PUMP (March 31, 1994)
  • K933335 — RIVER VIAL ADAPTER (March 1, 1994)
  • K915120 — TEF/PLATINUM PISTON (December 27, 1991)
  • K915121 — TEF/WIRE PISTON (December 23, 1991)
  • K913286 — H/A TOTAL-REGULAR, H/A TOTAL-OFFSET (December 18, 1991)
  • K913287 — H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET (December 18, 1991)

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