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FDA 510(k) Application Details - K973356
Device Classification Name
Prosthesis, Partial Ossicular Replacement
More FDA Info for this Device
510(K) Number
K973356
Device Name
Prosthesis, Partial Ossicular Replacement
Applicant
HEINZ KURZ
TUEBINGER STRASSE 3
DUSSLINGEN D-72144 DE
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Contact
DAGMAR S MASER
Other 510(k) Applications for this Contact
Regulation Number
874.3450
More FDA Info for this Regulation Number
Classification Product Code
ETB
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More FDA Info for this Product Code
Date Received
09/08/1997
Decision Date
11/21/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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