Clearance Summary
R & D BATTERIES, INC. PART # 5003, 5198, 5253 received FDA 510(k) clearance under submission number K933642, sponsored by R & D Batteries, 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 1994-01-10.
- Submission: K933642
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1994-01-10
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.