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510(k) K002446

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D by Sun Nuclear Corp. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2000
Date Received
August 9, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

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  • K013689 — RE-ENTRANT CHAMBER (July 2, 2002)
  • K021463 — MODEL 1133 IVD PC VERSION (June 6, 2002)
  • K011332 — RF-IVD WIRELESS DOSIMETER-MODEL 1133 (July 26, 2001)
  • K011466 — QED DIODE DETECTORS, MODELS 1112-1116 (June 6, 2001)
  • K010449 — IVD (IN VIVO DOSIMETER), MODEL 1131 (May 4, 2001)

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