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510(k) K942724

EXTERNAL NASAL SPLINT by Micromed Development Corp. — Product Code EPP

K942724 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "EXTERNAL NASAL SPLINT". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Micromed Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1994
Date Received
June 9, 1994
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 Micromed Development Corp.

  • K945105 — POLY/PLATINUM WIRE PISTON (May 14, 1996)
  • K945831 — DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT (January 20, 1995)
  • K945242 — NERVE MONITOR ELECTRODES/STIMULATOR PROBES (December 27, 1994)
  • K945108 — POLY PISTON (November 22, 1994)
  • K945106 — MICROMED TOTAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945438 — EDI-BUR MICRODRILL SYSTEMS (November 22, 1994)
  • K945104 — MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945107 — POLY-WIRE PISTON (November 22, 1994)
  • K943848 — COLLAR BUTTON VENTURI VENT TUBE (September 16, 1994)
  • K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)

Other clearances for product code EPP

  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 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)
  • K864934 — 'EXMOOR' SHAH SILICONE DISCS (January 28, 1987)
  • K863382 — CANNON NASAL SPLINT (October 7, 1986)

FDA data resources