Clearance Summary
GRAM-MA NEONATAL SC received FDA 510(k) clearance under submission number K853475, sponsored by Kentec Medical, 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 1985-09-05.
- Submission: K853475
- Applicant / Sponsor: Kentec Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2720
- Decision date: 1985-09-05
Classification & Regulation
This clearance is catalogued under FDA product code FRW and 21 CFR 880.2720, within the General Hospital review panel as a Class I device.