Clearance Summary
NUGARD NITILE GREY COLOR received FDA 510(k) clearance under submission number K102230, sponsored by Terang Nusa Sdn Bhd. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-09-10.
- Submission: K102230
- Applicant / Sponsor: Terang Nusa Sdn Bhd
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2010-09-10
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.