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510(k) K810024

BONNER BRACE by Bee Ent. — Product Code IQK

K810024 is an FDA 510(k) premarket notification submitted by Bee Ent. for the device "BONNER BRACE". The FDA issued a decision of Substantially Equivalent on January 23, 1981. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1981
Date Received
January 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cervical
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances for product code IQK

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 1993)
  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)
  • K832001 — HEAD-IMMOBILIZER (July 12, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)

FDA data resources