IR-192 IMPLANT -- MODIFICATION— 510(k) K923130

Name: FDA 510(k) clearance K923130
Creator: U.S. Food and Drug Administration
Published: 1992-09-21

Substantially Equivalent

Omnitron Intl., Inc.

FDA 510(k) clearance K923130 for IR-192 IMPLANT -- MODIFICATION, Substantially Equivalent on 1992-09-21. Applicant: Omnitron Intl., Inc.. Device class: 2.

Clearance details

Applicant: Omnitron Intl., Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1992-06-25
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lajke Charles, LA, US

Download summary PDF View on FDA.gov ↗

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