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510(k) K973587

EXMOOR TYMPANOCENTESIS KIT (TK/1) by Exmoor Plastics , Ltd. — Product Code JZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1998
Date Received
September 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Ear Suction
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)
  • K974365 — MILLS INCUS HA SLEEVE (January 22, 1998)

Other clearances for product code JZF

  • K862903 — MIDDLE EAR VIEWER AND FLUID COLLECTOR (November 24, 1986)
  • K853589 — SHAH SELF-CLEARING MASTOID SUCTION TUBE (December 23, 1985)
  • K841357 — MICRO FLUID APPLICATOR (August 24, 1984)
  • K822010 — RIGID SUCTION TIPS & RELATED ITEMS (August 12, 1982)