EXELO2, MODEL 4010— 510(k) K090639

Substantially Equivalent

Quantel Derma GmbH

FDA 510(k) clearance K090639 for EXELO2, MODEL 4010, Substantially Equivalent on 2009-10-29. Applicant: Quantel Derma GmbH. Device class: 2.

Clearance details

Applicant: Quantel Derma GmbH
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2009-03-10
Decision date: 2009-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bozeman, MT, US

Download summary PDF View on FDA.gov ↗

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