FDA 510(k) Application Details - K955613

Device Classification Name Prosthesis, Partial Ossicular Replacement

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510(K) Number K955613
Device Name Prosthesis, Partial Ossicular Replacement
Applicant MISTEN MEDICAL CORP.
7220 STOUT RD.
GERMANTOWN, TN US
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Contact GEORGE W MURRAY
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Regulation Number 874.3450

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Classification Product Code ETB
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Date Received 12/11/1995
Decision Date 12/22/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review N



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