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

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..

Clearance details

Applicant: Nordion International, Inc.
Product code: Code MOT
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.