Clearance Summary
R AND D BATTERY REPLACEMENT received FDA 510(k) clearance under submission number K933337, sponsored by R & D Batteries, 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 1994-04-05.
- Submission: K933337
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1994-04-05
Classification & Regulation
This clearance is catalogued under FDA product code KIJ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.