Home / 510(k) Clearances / K890599

510(k) K890599

HOOD NASAL SPLINT by Hood Laboratories — Product Code EPP

K890599 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "HOOD NASAL SPLINT". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Hood Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
February 6, 1989
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 Hood Laboratories

  • K921452 — ACOUSTIC RHINOMETER (July 8, 1993)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K905703 — KRUPIN EYE VALVE WITH DISK (March 15, 1991)
  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K897059 — HOOD SPEAKING VALVE (March 12, 1990)
  • K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE (August 7, 1989)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K885125 — KRUPIN EYE VALVE W/SCLERAL BUCKLE (January 24, 1989)
  • K882430 — HOOD TRACHEAL STOMA BUTTON (June 28, 1988)

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)
  • 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)
  • K864932 — 'EXMOOR' CAWOOD NASAL SPLINTS (March 4, 1987)
  • K864930 — 'EXMOOR' ATKINS NASAL SPLINT (March 4, 1987)
  • K864934 — 'EXMOOR' SHAH SILICONE DISCS (January 28, 1987)
  • K863382 — CANNON NASAL SPLINT (October 7, 1986)

FDA data resources