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510(k) K881665

OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR by Omnitron Intl., Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1988
Date Received
April 18, 1988
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.

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  • 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)
  • K911775 — OMNICATH IMPLANTED CATHETER AND DEPOT (May 8, 1991)

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