VibraPEP— 510(k) K153441

Substantially Equivalent

Medica Holdings, LLC

FDA 510(k) clearance K153441 for VibraPEP, Substantially Equivalent on 2016-03-25. Applicant: Medica Holdings, LLC. Device class: 2.

Clearance details

Applicant: Medica Holdings, LLC
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2015-11-27
Decision date: 2016-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, 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.