Home / 510(k) Clearances / K812342

510(k) K812342

ZEE EXTRICATION DEVICE by Zee Medical Products Co., Inc. — Product Code IQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
August 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Zee Medical Products Co., Inc.

  • K823501 — ZEE SPHYGMOMANOMETER (January 21, 1983)
  • K813156 — ULTRA-WIDE SAFETY SPECTACLE FRAME (December 14, 1981)
  • K813016 — ZEE TRACTION SPLINT (November 24, 1981)
  • K812814 — ZEE SURGICAL INSTRUMENTS (November 6, 1981)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)
  • K812284 — ZEE ELECTRODE-GEL (September 8, 1981)
  • K812022 — ZEE MANUAL RESUSCITATOR (July 31, 1981)

Other clearances for product code IQF

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K791350 — POPE AMBULATORY HALO VEST (August 3, 1979)
  • K781761 — KENDRICK EXTRICATION DEVICE (October 27, 1978)
  • K780489 — SPINE BOARD (April 12, 1978)