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FDA 510(k), K080004, DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
FDA 510(k), K080004, DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
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510(K) Number: K080004
Device Name: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
Manufacturer: TAMMY B CARREA
Device Classification Name: Dosimeter, Ionizing Radiation, Implanted
Regulation Number: NZT
Classification Product Code: KXA
Date Received: 01/02/2008
Decision Date: 01/23/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
Manufacturer: TAMMY B CARREA
Device Classification Name: Dosimeter, Ionizing Radiation, Implanted
Regulation Number: NZT
Classification Product Code: KXA
Date Received: 01/02/2008
Decision Date: 01/23/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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