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510(k) K003662

SPINE WORKS COLLAR by Spine Works — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
November 28, 2000
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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