HEINE LAMBDA 100— 510(k) K944156

Substantially Equivalent

Heine USA , Ltd.

FDA 510(k) clearance K944156 for HEINE LAMBDA 100, Substantially Equivalent on 1995-01-12. Applicant: Heine USA , Ltd.. Device class: 1.

Clearance details

Applicant: Heine USA , Ltd.
Product code: Code HOX
Device class: Class 1
Regulation: 21 CFR 886.1150
Advisory panel: Ophthalmic
Date received: 1994-08-26
Decision date: 1995-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cary, NC, 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.