Basic, Dominant Flex, KV-6— 510(k) K150134

Substantially Equivalent

Medela AG

FDA 510(k) clearance K150134 for Basic, Dominant Flex, KV-6, Substantially Equivalent on 2015-04-21. Applicant: Medela AG. Device class: 2.

Clearance details

Applicant: Medela AG
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2015-01-21
Decision date: 2015-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.