NFM · Class II · 21 CFR 886.3320

FDA Product Code NFM: Expander, Tissue, Orbital

Leading manufacturers include Iop, Inc. and Innovia, LLC.

2
Total
2
Cleared
173d
Avg days
2001
Since

FDA 510(k) Cleared Expander, Tissue, Orbital Devices (Product Code NFM)

2 devices
1–2 of 2
Cleared Aug 08, 2006
ORBITAL TISSUE EXPANDER (OTE)
K060151
Innovia, LLC
Ophthalmic · 200d
Cleared Aug 13, 2001
OSMED TISSUE EXPANDER
K010852
Iop, Inc.
Ophthalmic · 145d

About Product Code NFM - Regulatory Context