Clearance Summary
OSCILLATING KNIFE AND ACCESSORIES received FDA 510(k) clearance under submission number K781412, sponsored by Codman & Shurtleff, 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 1978-10-11.
- Submission: K781412
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1978-10-11
Classification & Regulation
This clearance is catalogued under FDA product code HMY and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.