Clearance Summary
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 received FDA 510(k) clearance under submission number K962740, sponsored by Medi-Flex Hospital Products, 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 1996-09-06.
- Submission: K962740
- Applicant / Sponsor: Medi-Flex Hospital Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1996-09-06
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.