510(k) K003338
K003338 is an FDA 510(k) premarket notification submitted by Integrated Orbital Implants, Inc. for the device "BIO-EYE II ORBITAL IMPLANT". The FDA issued a decision of Substantially Equivalent on February 7, 2001. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Integrated Orbital Implants, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2001
- Date Received
- October 25, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Sphere
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type