Clearance Summary
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY received FDA 510(k) clearance under submission number K951450, sponsored by Strenumed, 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 1995-05-17.
- Submission: K951450
- Applicant / Sponsor: Strenumed, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1995-05-17
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.