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FDA 510(k) Application Details - K013573
Device Classification Name
Prosthesis, Partial Ossicular Replacement
More FDA Info for this Device
510(K) Number
K013573
Device Name
Prosthesis, Partial Ossicular Replacement
Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM 1017 AP NL
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/2001
Decision Date
11/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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