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510(k) K812019

LOXLEY EMERGENCY CERVICAL COLLAR by Loxley Medical — Product Code IQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
July 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)