Home / 510(k) Clearances / K864934

510(k) K864934

'EXMOOR' SHAH SILICONE DISCS by Exmoor Plastics , Ltd. — Product Code EPP

K864934 is an FDA 510(k) premarket notification submitted by Exmoor Plastics , Ltd. for the device "'EXMOOR' SHAH SILICONE DISCS". The FDA issued a decision of Substantially Equivalent on January 28, 1987. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Exmoor Plastics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1987
Date Received
December 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Nasal
Device Class
Class I
Regulation Number
874.5800
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)
  • 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 EPP

  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 1994)
  • K942724 — EXTERNAL NASAL SPLINT (July 8, 1994)
  • K895502 — MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (December 8, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K882244 — RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT (June 23, 1988)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K864933 — 'EXMOOR' SHAH & MACKAY NASAL SPLINTS (March 4, 1987)
  • K864930 — 'EXMOOR' ATKINS NASAL SPLINT (March 4, 1987)
  • K864932 — 'EXMOOR' CAWOOD NASAL SPLINTS (March 4, 1987)
  • K863382 — CANNON NASAL SPLINT (October 7, 1986)

FDA data resources