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510(k) K042746

PET-DOSE by Comecer S.R.L. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2004
Date Received
October 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

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