SMARTGRAFT 30 SYSTEM— 510(k) K141591

Substantially Equivalent

Ingeneron, Inc.

FDA 510(k) clearance K141591 for SMARTGRAFT 30 SYSTEM, Substantially Equivalent on 2014-09-24. 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: 2014-06-13
Decision date: 2014-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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