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510(k) K882877

JMS CERVICAL TRACTION DEVICE/HALO DEVICE by Jerome Medical — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1988
Date Received
July 11, 1988
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

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  • 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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