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510(k) K160933

Discovery NM 750b Bopsy by Ge Healthcare — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2016
Date Received
April 4, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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