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510(k) K830348

VINYL EXTRICATION COLLAR by Deip Enterprises, Inc. — Product Code IQK

K830348 is an FDA 510(k) premarket notification submitted by Deip Enterprises, Inc. for the device "VINYL EXTRICATION COLLAR". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490. Deip Enterprises, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
February 3, 1983
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 by Deip Enterprises, Inc.

  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)
  • K830350 — CERVICAL PILLOW (March 9, 1983)
  • K830349 — SAC-RO-FORM INSERT & BINDER (March 9, 1983)

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)
  • K830350 — CERVICAL PILLOW (March 9, 1983)

FDA data resources