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510(k) K013689

RE-ENTRANT CHAMBER by Sun Nuclear Corp. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
November 6, 2001
Clearance Type
Traditional
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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  • K002446 — RE-ENTRANT CHAMBER, MODEL 1008 OR 44D (October 23, 2000)

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