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510(k) K963899

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) by Exmoor Plastics , Ltd. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1997
Date Received
September 27, 1996
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

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  • K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (January 27, 1998)
  • K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1) (January 23, 1998)

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