AGRAM SPYRAL ELECTRODE— 510(k) K934779

Substantially Equivalent

Agram Export-Import Co.

FDA 510(k) clearance K934779 for AGRAM SPYRAL ELECTRODE, Substantially Equivalent on 1995-03-14. Applicant: Agram Export-Import Co.. Device class: 2.

Clearance details

Applicant: Agram Export-Import Co.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 1993-10-06
Decision date: 1995-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Rock, NJ, US

Download summary PDF View on FDA.gov ↗

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