COURIER II— 510(k) K953514

Substantially Equivalent

Gammex, Inc.

FDA 510(k) clearance K953514 for COURIER II, Substantially Equivalent on 1995-10-07. Applicant: Gammex, Inc.. Device class: 1.

Clearance details

Applicant: Gammex, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1995-07-26
Decision date: 1995-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

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