510(k) K182017
K182017 is an FDA 510(k) premarket notification submitted by Addent, Inc. for the device "Compex HD". The FDA issued a decision of Substantially Equivalent on April 29, 2019. The device falls under product code QGO (Composite Resin Warmer), a Class I device regulated under 21 CFR 872.6100. Addent, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2019
- Date Received
- July 27, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Composite Resin Warmer
- Device Class
- Class I
- Regulation Number
- 872.6100
- Review Panel
- DE
- Submission Type
Intended to warm composite materials prior to use