Clearance Summary
WOUND DRAINAGE HOLDER received FDA 510(k) clearance under submission number K973183, sponsored by R & D Medical Products, Inc.. 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 1998-01-23.
- Submission: K973183
- Applicant / Sponsor: R & D Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1998-01-23
Classification & Regulation
This clearance is catalogued under FDA product code KGZ and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.