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510(k) K791681

THE DENVER SPLINT by Xomed, Inc. — Product Code EPP

K791681 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "THE DENVER SPLINT". The FDA issued a decision of Substantially Equivalent on October 22, 1979. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1979
Date Received
August 28, 1979
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 Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

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)
  • K864930 — 'EXMOOR' ATKINS NASAL SPLINT (March 4, 1987)
  • K864933 — 'EXMOOR' SHAH & MACKAY NASAL SPLINTS (March 4, 1987)
  • K864932 — 'EXMOOR' CAWOOD NASAL SPLINTS (March 4, 1987)
  • K864934 — 'EXMOOR' SHAH SILICONE DISCS (January 28, 1987)

FDA data resources