LANE ONE— 510(k) K832770

Substantially Equivalent

Loredan Biomedical, Inc.

FDA 510(k) clearance K832770 for LANE ONE, Substantially Equivalent on 1983-09-26. Applicant: Loredan Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Loredan Biomedical, Inc.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1983-08-16
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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