Clearance Summary
SECURE-SITE received FDA 510(k) clearance under submission number K941098, sponsored by Op-Co Medical Products , Ltd.. 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 1995-08-09.
- Submission: K941098
- Applicant / Sponsor: Op-Co Medical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1995-08-09
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.