510(k) K121318
K121318 is an FDA 510(k) premarket notification submitted by Perma Laboratories for the device "PROSOFT". The FDA issued a decision of Substantially Equivalent on June 6, 2012. The device falls under product code EBP (Reliner, Denture, Over The Counter), a Class II device regulated under 21 CFR 872.3560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2012
- Date Received
- May 2, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Reliner, Denture, Over The Counter
- Device Class
- Class II
- Regulation Number
- 872.3560
- Review Panel
- DE
- Submission Type