SKYLARK GB 1000— 510(k) K861214

Substantially Equivalent

Peleg Intl. Co.

FDA 510(k) clearance K861214 for SKYLARK GB 1000, Substantially Equivalent on 1986-06-18. Applicant: Peleg Intl. Co.. Device class: 2.

Clearance details

Applicant: Peleg Intl. Co.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1986-03-31
Decision date: 1986-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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