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510(k) K911775

OMNICATH IMPLANTED CATHETER AND DEPOT by Omnitron Intl., Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1991
Date Received
April 1, 1991
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 Omnitron Intl., Inc.

  • K901615 — PULMOCATH INTRABRONCHIAL CATHETER (November 27, 1992)
  • K923130 — IR-192 IMPLANT -- MODIFICATION (September 21, 1992)
  • K920431 — OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE (May 29, 1992)
  • K913908 — OMNITRON GYN APPLICATOR SYSTEM (March 6, 1992)
  • K915253 — IR-192 IMPLANT, MODIFICATION (February 27, 1992)
  • K881665 — OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR (August 11, 1988)

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  • K190839 — GammaTile (January 23, 2020)
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