Clearance Summary
MSP OPHTHALMIC (EYE SPUD) received FDA 510(k) clearance under submission number K931449, sponsored by Medical Sterile Products, 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 1993-08-31.
- Submission: K931449
- Applicant / Sponsor: Medical Sterile Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1993-08-31
Classification & Regulation
This clearance is catalogued under FDA product code HNA and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.