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510(k) K972735

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) by Mednet Locator, Inc. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
July 22, 1997
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 Mednet Locator, Inc.

  • K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO (August 8, 2000)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K974174 — ULTRABUR (March 10, 1998)
  • K972737 — CAUSSE PISTON (September 5, 1997)
  • K972734 — PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) (September 5, 1997)
  • K972126 — MYRINGOTOMY TUBE (July 29, 1997)
  • K972400 — MYRINGOTOMY TUBE - BOBBIN WITH TAB (July 23, 1997)
  • K971943 — MYRINGOTOMY TUBE (July 23, 1997)

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  • K091187 — GRACE DYNAMIC TORP (September 14, 2009)
  • K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0 (March 23, 2009)
  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (October 1, 2004)
  • K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
  • K002378 — MODULAR PORP AND TORP MODEL TBD (August 29, 2000)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO (August 8, 2000)
  • K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (July 10, 2000)