510(k) K932012
K932012 is an FDA 510(k) premarket notification submitted by Chemichl, Inc. for the device "CAPS". The FDA issued a decision of Substantially Equivalent on November 3, 1993. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1993
- Date Received
- April 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Teeth, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.3920
- Review Panel
- DE
- Submission Type