WANDY DISPERSVIE ELECTRODE— 510(k) K121268

Substantially Equivalent

Bio-Med USA, Inc.

FDA 510(k) clearance K121268 for WANDY DISPERSVIE ELECTRODE, Substantially Equivalent on 2012-12-20. Applicant: Bio-Med USA, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Med USA, Inc.
Product code: Code ODR
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2012-04-26
Decision date: 2012-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paterson, NJ, US

Download summary PDF View on FDA.gov ↗

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