510(k) K082723
K082723 is an FDA 510(k) premarket notification submitted by Grind Guard Technologies, LLC for the device "GRINDGUARD". The FDA issued a decision of Substantially Equivalent on Aug 31, 2009. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Grind Guard Technologies, LLC has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 2009
- Date Received
- Sep 17, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)