Clearance Summary
SPYROFLEX WOUND CLOSURES received FDA 510(k) clearance under submission number K921775, sponsored by Polymint Industrial Co. , Ltd.. 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 1992-05-19.
- Submission: K921775
- Applicant / Sponsor: Polymint Industrial Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1992-05-19
Classification & Regulation
This clearance is catalogued under FDA product code FPX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.