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510(k) K822885

HALO TRACTION CERVICAL IMMOBILIZATION by Orthopedic Systems, Inc. — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1982
Date Received
September 28, 1982
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

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  • 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)