510(k) K060151
K060151 is an FDA 510(k) premarket notification submitted by Innovia, LLC for the device "ORBITAL TISSUE EXPANDER (OTE)". The FDA issued a decision of Substantially Equivalent on August 8, 2006. The device falls under product code NFM (Expander, Tissue, Orbital), a Class II device regulated under 21 CFR 886.3320. Innovia, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2006
- Date Received
- January 20, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Expander, Tissue, Orbital
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type