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510(k) K081281

OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) by Nucletron Corporation — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2008
Date Received
May 6, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K080929 — ONCENTRA GYN (April 16, 2008)
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  • K073107 — VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 (December 7, 2007)
  • K061354 — MICROSELECTRON V3, MODEL 106.990 (August 17, 2006)

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