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510(k) K944967

TOMO-LINK by GE Medical Systems — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1994
Date Received
October 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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