Clearance Summary
KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 received FDA 510(k) clearance under submission number K980508, sponsored by Micro Specialties, 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 1998-05-01.
- Submission: K980508
- Applicant / Sponsor: Micro Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1998-05-01
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.