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510(k) K981045

EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS by Exmoor Plastics , Ltd. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1998
Date Received
March 20, 1998
Clearance Type
Traditional
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 Exmoor Plastics , Ltd.

  • K093863 — EPIDRUM (May 10, 2010)
  • K990366 — EXMOOR SUCTION CLEARANCE KIT (March 5, 1999)
  • K980828 — EXMOOR MYRINGOTOMY KIT (October 22, 1998)
  • K981143 — DILKES LASER/SUCTION CANNULAE (September 14, 1998)
  • K972700 — EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATT (July 16, 1998)
  • K981088 — MILLS COLUMELLA PROSTHESIS (June 5, 1998)
  • K974008 — PFLEIDERER'S INTRATYMPANIC CATHETER (May 13, 1998)
  • K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (January 27, 1998)
  • K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1) (January 23, 1998)
  • K974365 — MILLS INCUS HA SLEEVE (January 22, 1998)

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