GYREX 2T-PRESTIGE— 510(k) K970005

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K970005 for GYREX 2T-PRESTIGE, Substantially Equivalent on 1997-03-28. Applicant: Elscint, Inc..

Clearance details

Applicant: Elscint, Inc.
Product code: Code LNI
Advisory panel: Radiology
Date received: 1997-01-02
Decision date: 1997-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

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