NORAPAD PLAIN; NORAPAD TA— 510(k) K014268

Substantially Equivalent

Perlei Medical, Inc.

FDA 510(k) clearance K014268 for NORAPAD PLAIN; NORAPAD TA, Substantially Equivalent on 2002-03-27. Applicant: Perlei Medical, Inc.. Device class: 2.

Clearance details

Applicant: Perlei Medical, Inc.
Product code: Code HBA
Device class: Class 2
Regulation: 21 CFR 882.4700
Advisory panel: Neurology
Date received: 2001-12-27
Decision date: 2002-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, 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.