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510(k) K142325

Veenstra Instruments VDC-506 Dose Calibrator by Comecer Netherlands B.V. — Product Code KPT

K142325 is an FDA 510(k) premarket notification submitted by Comecer Netherlands B.V. for the device "Veenstra Instruments VDC-506 Dose Calibrator". The FDA issued a decision of Substantially Equivalent on September 18, 2014. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2014
Date Received
August 20, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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FDA data resources