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510(k) K945105

POLY/PLATINUM WIRE PISTON by Micromed Development Corp. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1996
Date Received
October 18, 1994
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 Micromed Development Corp.

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  • K945108 — POLY PISTON (November 22, 1994)
  • K945104 — MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945106 — MICROMED TOTAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945438 — EDI-BUR MICRODRILL SYSTEMS (November 22, 1994)
  • K945107 — POLY-WIRE PISTON (November 22, 1994)
  • K943848 — COLLAR BUTTON VENTURI VENT TUBE (September 16, 1994)
  • K943847 — BOBBIN STYLE VENTURI VENT TUBE (September 2, 1994)
  • K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)

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