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510(k) K903465

IR-192 IMPLANT by Rads S.L., Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1990
Date Received
August 1, 1990
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

Other clearances by Rads S.L., Inc.

  • K874895 — IR-192 IMPLANT (February 25, 1988)
  • K844248 — IR-192 IMPLANT (April 10, 1985)

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