510(k) K832500
K832500 is an FDA 510(k) premarket notification submitted by Chema-Scutum, Inc. for the device "CS-11". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code EBE (Coating, Denture Hydrophilic, Resin), a Class II device regulated under 21 CFR 872.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1983
- Date Received
- July 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Denture Hydrophilic, Resin
- Device Class
- Class II
- Regulation Number
- 872.3300
- Review Panel
- DE
- Submission Type