Clearance Summary
DELTA received FDA 510(k) clearance under submission number K945117, sponsored by Pelton & Crane Co.. 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 1997-02-28.
- Submission: K945117
- Applicant / Sponsor: Pelton & Crane Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 1997-02-28
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.