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510(k) K972734

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) by Mednet Locator, Inc. — Product Code ETB

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
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
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)
  • K972735 — TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (September 5, 1997)
  • K972737 — CAUSSE PISTON (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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