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510(k) K930153

SYSTEM III HALO RING by Jerome Medical — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
January 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Jerome Medical

  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K930021 — J TONGS (December 6, 1995)
  • K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE (September 30, 1988)
  • K870053 — TORQUEDRIVER WRENCH (March 11, 1987)
  • K864969 — JMS HALO APPLICATION TRAY (February 18, 1987)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K822780 — CERVICAL BRACE (October 6, 1982)
  • K821582 — WARM'N FORM SPORTS SUPPORTS (June 10, 1982)

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