FDA 510(k) Application Details - K993234

Device Classification Name Prosthesis, Partial Ossicular Replacement

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510(K) Number K993234
Device Name Prosthesis, Partial Ossicular Replacement
Applicant MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN, MN 55121 US
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Contact CHARLES GROTE
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Regulation Number 874.3450

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Classification Product Code ETB
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Date Received 09/27/1999
Decision Date 11/10/1999
Decision SESE - SUBST EQUIV
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



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