Clearance Summary
SURGICAL INSTRUMENT KIT, DISPOSABLE received FDA 510(k) clearance under submission number K923175, sponsored by Ulti-Med Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-06-17.
- Submission: K923175
- Applicant / Sponsor: Ulti-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1993-06-17
Classification & Regulation
This clearance is catalogued under FDA product code FMC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.