Clearance Summary
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 received FDA 510(k) clearance under submission number K973850, sponsored by Alexander Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1997-11-12.
- Submission: K973850
- Applicant / Sponsor: Alexander Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 1997-11-12
Classification & Regulation
This clearance is catalogued under FDA product code HFO and 21 CFR 884.2700, within the Obstetrics/Gynecology review panel as a Class II device.