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510(k) K990085

MILLENNIUM MLC -120 by Varian Assoc., Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1999
Date Received
January 11, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K980601 — VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE (October 21, 1998)
  • K955844 — APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (July 26, 1996)
  • K954467 — CADPLAN BT (March 15, 1996)
  • K955774 — VARIS PORTALVISION (March 15, 1996)
  • K943224 — VARIAN MULTILEAF COLLIMATOR (February 2, 1996)
  • K952913 — APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER (November 22, 1995)

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