Clearance Summary
X-PAK received FDA 510(k) clearance under submission number K791917, sponsored by Contemporary Surgical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1979-10-30.
- Submission: K791917
- Applicant / Sponsor: Contemporary Surgical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1979-10-30
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.