AM-PAK— 510(k) K912436

Substantially Equivalent

Cns, Inc.

FDA 510(k) clearance K912436 for AM-PAK, Substantially Equivalent on 1991-10-18. Applicant: Cns, Inc.. Device class: 2.

Clearance details

Applicant: Cns, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 1991-06-03
Decision date: 1991-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, 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.