510(k) K813190
K813190 is an FDA 510(k) premarket notification submitted by Leonard Russo Co. for the device "SOFT PLATE CUSHION". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code EHS (Cushion, Denture, Over The Counter), a Class II device regulated under 21 CFR 872.3540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1982
- Date Received
- November 16, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Denture, Over The Counter
- Device Class
- Class II
- Regulation Number
- 872.3540
- Review Panel
- DE
- Submission Type