ORBITAL TISSUE EXPANDER (OTE)— 510(k) K060151

Substantially Equivalent

Innovia, LLC

FDA 510(k) clearance K060151 for ORBITAL TISSUE EXPANDER (OTE), Substantially Equivalent on 2006-08-08. Applicant: Innovia, LLC. Device class: 2.

Clearance details

Applicant: Innovia, LLC
Product code: Code NFM
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2006-01-20
Decision date: 2006-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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