Clearance Summary
BLOOD COLLECTION SET TYPE H received FDA 510(k) clearance under submission number K771269, sponsored by Berman, Pcp & Consultants, 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 1977-09-12.
- Submission: K771269
- Applicant / Sponsor: Berman, Pcp & Consultants, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1977-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.