AT64 SCR— 510(k) K930577

Substantially Equivalent

Autoject Systems, Inc.

FDA 510(k) clearance K930577 for AT64 SCR, Substantially Equivalent on 1995-05-18. Applicant: Autoject Systems, Inc.. Device class: 2.

Clearance details

Applicant: Autoject Systems, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1993-02-04
Decision date: 1995-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Dale, IL, US

Download summary PDF View on FDA.gov ↗

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