SABRE COMPAC— 510(k) K011842

Substantially Equivalent

Sle Limited

FDA 510(k) clearance K011842 for SABRE COMPAC, Substantially Equivalent on 2002-01-08. Applicant: Sle Limited. Device class: 2.

Clearance details

Applicant: Sle Limited
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2001-06-12
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, 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.