Clearance Summary
SEE-THRU SELF SEALING STERILIZATION POUCH received FDA 510(k) clearance under submission number K940807, sponsored by Asep-Pro, 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 1994-11-18.
- Submission: K940807
- Applicant / Sponsor: Asep-Pro, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 1994-11-18
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.