510(k) K042503

KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM by Heinz Kurz GmbH Medizintechnik — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2004
Date Received
September 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type