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510(k) K930021

J TONGS by Jerome Medical — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
January 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tong, Skull For Traction
Device Class
Class II
Regulation Number
882.5960
Review Panel
NE
Submission Type

Other clearances by Jerome Medical

  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K930153 — SYSTEM III HALO RING (August 6, 1993)
  • 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)

Other clearances for product code HAX

  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (May 25, 2007)
  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K023959 — JEROME GLASS RING (February 21, 2003)
  • K003662 — SPINE WORKS COLLAR (July 9, 2001)
  • K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (February 18, 1999)
  • K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS (October 12, 1995)
  • K924606 — BREMER IMAGING TONGS-MRI MODEL (September 9, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)