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510(k) K915121

TEF/WIRE PISTON by River Medical, Inc. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1991
Date Received
November 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
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)
  • 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)
  • K913287 — H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET (December 18, 1991)
  • K913285 — PTFE PISTON (December 18, 1991)

Other clearances for product code ETB

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  • K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES P (December 2, 2013)
  • K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (February 8, 2013)
  • K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (April 17, 2008)
  • K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, (December 6, 2006)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)
  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K021479 — CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (May 21, 2002)