Clearance Summary
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 received FDA 510(k) clearance under submission number K091097, sponsored by Promedical Products Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-05-27.
- Submission: K091097
- Applicant / Sponsor: Promedical Products Co., Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2009-05-27
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.