FDA 510(k) Application Details - K964798

Device Classification Name Prosthesis, Partial Ossicular Replacement

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510(K) Number K964798
Device Name Prosthesis, Partial Ossicular Replacement
Applicant ANTHONY D. PRESCOTT
8624 NORTH LAKE COVE
MEMPHIS, TN 38002 US
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Contact ANTHONY D PRESCOTT
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Regulation Number 874.3450

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Classification Product Code ETB
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Date Received 11/29/1996
Decision Date 01/02/1997
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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