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510(k) K010442

KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 by Heinz Kurz — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2001
Date Received
February 14, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

Other clearances by Heinz Kurz

  • K991324 — TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 00 (May 18, 1999)
  • K990923 — TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 (March 31, 1999)
  • K973356 — K-PISTON WITH BAND HOOK /ANGULAR PISTON (November 21, 1997)
  • K972492 — BELL PROSTHESIS (PARTIAL) (August 4, 1997)

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