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510(k) K913908

OMNITRON GYN APPLICATOR SYSTEM by Omnitron Intl., Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1992
Date Received
August 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
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)
  • K915253 — IR-192 IMPLANT, MODIFICATION (February 27, 1992)
  • K911775 — OMNICATH IMPLANTED CATHETER AND DEPOT (May 8, 1991)
  • K881665 — OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR (August 11, 1988)

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  • K241965 — Catheter Surface Flap Applicator Set (GM11011830) (October 29, 2024)