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510(k) K913286

H/A TOTAL-REGULAR, H/A TOTAL-OFFSET by River Medical, Inc. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1991
Date Received
July 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type

Other clearances by River Medical, Inc.

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  • 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)
  • K943692 — SMART DOSE(TM) (April 28, 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)
  • K913285 — PTFE PISTON (December 18, 1991)

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