510(k) K000151
K000151 is an FDA 510(k) premarket notification submitted by Integrated Orbital Implants, Inc. for the device "PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE". The FDA issued a decision of Substantially Equivalent on April 10, 2000. The device falls under product code MQU (Ocular Peg), 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
- April 10, 2000
- Date Received
- January 19, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ocular Peg
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type