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510(k) K945104

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

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
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

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  • K943847 — BOBBIN STYLE VENTURI VENT TUBE (September 2, 1994)
  • K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)

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