SMARTGRAFT 200 SYSTEM— 510(k) K141713

Substantially Equivalent

Ingeneron, Inc.

FDA 510(k) clearance K141713 for SMARTGRAFT 200 SYSTEM, Substantially Equivalent on 2014-10-28. Applicant: Ingeneron, Inc.. Device class: 2.

Clearance details

Applicant: Ingeneron, Inc.
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2014-06-25
Decision date: 2014-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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