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510(k) K901615

PULMOCATH INTRABRONCHIAL CATHETER by Omnitron Intl., Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1992
Date Received
April 6, 1990
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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  • 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)
  • K881665 — OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR (August 11, 1988)

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