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Device Classification
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NFM — Expander, Tissue, Orbital
Class II
FDA Device Classification
Classification Details
Product Code
NFM
Device Class
Class II
Regulation Number
886.3320
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K060151
innovia
ORBITAL TISSUE EXPANDER (OTE)
August 8, 2006
K010852
iop
OSMED TISSUE EXPANDER
August 13, 2001