Clearance Summary
PART #860070 ULTRAPAK & #860075 ULTRAPAK received FDA 510(k) clearance under submission number K871474, sponsored by Medical Technical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-08-10.
- Submission: K871474
- Applicant / Sponsor: Medical Technical Products
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1987-08-10
Classification & Regulation
This clearance is catalogued under FDA product code HOC and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.