TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM— 510(k) K862415

Name: FDA 510(k) clearance K862415
Creator: U.S. Food and Drug Administration
Published: 1986-07-01

Substantially Equivalent

Parexel Intl. Corp.

FDA 510(k) clearance K862415 for TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM, Substantially Equivalent on 1986-07-01. Applicant: Parexel Intl. Corp.. Device class: 1.

Clearance details

Applicant: Parexel Intl. Corp.
Product code: Code IWZ
Device class: Class 1
Regulation: 21 CFR 892.1840
Advisory panel: Radiology
Date received: 1986-06-25
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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