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510(k) K915800

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN by Bremer Medical, Inc. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1992
Date Received
December 24, 1991
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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