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510(k) K862496

MICROTEK INTRANASAL SPLINT by Microtek Medical, Inc. — Product Code EPP

K862496 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "MICROTEK INTRANASAL SPLINT". The FDA issued a decision of Substantially Equivalent on July 14, 1986. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1986
Date Received
July 1, 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 Microtek Medical, Inc.

  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K110358 — VENODYNE V810 (May 5, 2011)
  • K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (February 23, 2011)
  • K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA (January 25, 2007)
  • K060200 — MICROTEK MEDICAL WARMING DRAPE (May 31, 2006)
  • K050322 — MICROTEK EQUIPMENT DRAPES (May 17, 2005)
  • K022903 — CHILLBUSTER (November 27, 2002)
  • K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (May 16, 2002)
  • K011318 — VENODYNE DVT ADVANTAGE PLUS (October 25, 2001)
  • K001802 — VENODYNE DVT ADVANTAGE MODEL 610 (January 9, 2001)

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