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510(k) K972700

EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) by Exmoor Plastics , Ltd. — Product Code KHJ

K972700 is an FDA 510(k) premarket notification submitted by Exmoor Plastics , Ltd. for the device "EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)". The FDA issued a decision of Substantially Equivalent on July 16, 1998. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Exmoor Plastics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1998
Date Received
June 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
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)
  • 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)
  • K974365 — MILLS INCUS HA SLEEVE (January 22, 1998)

Other clearances for product code KHJ

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K161000 — Biodesign Otologic Repair Graft (May 11, 2016)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)
  • K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (September 12, 2013)
  • K121360 — BIODESIGN ENT REPAIR GRAFT (February 27, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL (June 6, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (December 9, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)

FDA data resources