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510(k) K974224

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT by Exmoor Plastics , Ltd. — Product Code ESZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1998
Date Received
November 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Shunt, Endolymphatic
Device Class
Class II
Regulation Number
874.3820
Review Panel
EN
Submission Type

Other clearances by Exmoor Plastics , Ltd.

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  • 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)
  • K981045 — EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS (May 20, 1998)
  • K974008 — PFLEIDERER'S INTRATYMPANIC CATHETER (May 13, 1998)
  • K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1) (January 23, 1998)
  • K974365 — MILLS INCUS HA SLEEVE (January 22, 1998)

Other clearances for product code ESZ

  • K952227 — C-FLEX ENDOLYMPHATIC SHUNT (June 16, 1995)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K834094 — AUSTIN ENDOLYMPH DISPERSMENT SHUNT (September 20, 1984)