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510(k) K945106

MICROMED TOTAL REGULAR AND PARTIAL OFFSET by Micromed Development Corp. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
October 18, 1994
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

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  • K945108 — POLY PISTON (November 22, 1994)
  • K945438 — EDI-BUR MICRODRILL SYSTEMS (November 22, 1994)
  • K945107 — POLY-WIRE PISTON (November 22, 1994)
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  • 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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