Clearance Summary
RULE, PUPILLARY received FDA 510(k) clearance under submission number K873440, sponsored by Allegheny Plastics, 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 1987-09-21.
- Submission: K873440
- Applicant / Sponsor: Allegheny Plastics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1190
- Decision date: 1987-09-21
Classification & Regulation
This clearance is catalogued under FDA product code HMM and 21 CFR 886.1190, within the Ophthalmic review panel as a Class I device.