Clearance Summary
FRIGITRONICS ACC-1000 CAPSULE CUTTER received FDA 510(k) clearance under submission number K872362, sponsored by Frigitronics of Connecticut, 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 1987-07-27.
- Submission: K872362
- Applicant / Sponsor: Frigitronics of Connecticut, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1987-07-27
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.