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510(k) K820366

BECSIC COLLAR by Blackstone & Breglio Industries — Product Code IQK

K820366 is an FDA 510(k) premarket notification submitted by Blackstone & Breglio Industries for the device "BECSIC COLLAR". The FDA issued a decision of Substantially Equivalent on March 1, 1982. 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
March 1, 1982
Date Received
February 9, 1982
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)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K896042 — MEDICAL DISPOSABLE BEDDING (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)
  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)

FDA data resources