Clearance Summary
SERAGARD INJECTION PATCH received FDA 510(k) clearance under submission number K001240, sponsored by Platinum Services, 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 2000-06-21.
- Submission: K001240
- Applicant / Sponsor: Platinum Services, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 2000-06-21
Classification & Regulation
This clearance is catalogued under FDA product code KGX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.