Clearance Summary
ATEK SURGICAL GOWNS received FDA 510(k) clearance under submission number K100971, sponsored by Hangzhou Atek Medical & Textile Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-09-27.
- Submission: K100971
- Applicant / Sponsor: Hangzhou Atek Medical & Textile Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2010-09-27
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.