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510(k) K924901

DEANS DISPOSABLE T-TUBE INSERTER by Exmoor Plastics , Ltd. — Product Code JYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1993
Date Received
September 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Inserter, Myringotomy Tube
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Exmoor Plastics , Ltd.

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  • 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)
  • K981045 — EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS (May 20, 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)

Other clearances for product code JYM

  • K870978 — T-TUBE INSERTER (March 19, 1987)
  • K822349 — ARMSTRONG V TUBE SUCTION INSERTER (September 13, 1982)
  • K822348 — TYTAN TUBE INSERTER (September 7, 1982)