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510(k) K955613

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Misten Medical Corp. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1995
Date Received
December 11, 1995
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 Misten Medical Corp.

  • K962163 — MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL (July 25, 1996)
  • K955616 — MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE (January 17, 1996)
  • K955615 — MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS (December 22, 1995)

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