510(k) K212787
K212787 is an FDA 510(k) premarket notification submitted by Wuhan Greentek Pty , Ltd. for the device "GT5 conductive & abrasive gel". The FDA issued a decision of Substantially Equivalent on November 8, 2021. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Wuhan Greentek Pty , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2021
- Date Received
- September 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type