510(k) K030832
K030832 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "PRIMOSPLINT SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 17, 2003. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 17, 2003
- Date Received
- Mar 17, 2003
- 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)