GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0— 510(k) K963497

Name: FDA 510(k) clearance K963497
Creator: U.S. Food and Drug Administration
Published: 1996-11-08

Substantially Equivalent

Nordion International, Inc.

FDA 510(k) clearance K963497 for GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0, Substantially Equivalent on 1996-11-08. Applicant: Nordion International, Inc.. Device class: Unclassified.

Clearance details

Applicant: Nordion International, Inc.
Product code: Code MOT
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-09-03
Decision date: 1996-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, Ontario, CA

Download summary PDF View on FDA.gov ↗

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