Clearance Summary
MODIFICATION TO ZENIEVA received FDA 510(k) clearance under submission number K082865, sponsored by Gorbec Pharmaceutical Services, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-10-23.
- Submission: K082865
- Applicant / Sponsor: Gorbec Pharmaceutical Services, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4022
- Decision date: 2008-10-23
Classification & Regulation
This clearance is catalogued under FDA product code NAE and 21 CFR 878.4022, within the General, Plastic Surgery review panel as a Class I device.