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510(k) K980689

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM by Friddle'S Orthopedic Appliances, Inc. — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1999
Date Received
February 23, 1998
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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