510(k) K800371
K800371 is an FDA 510(k) premarket notification submitted by Williams Gold Refining Co., Inc. for the device "WILL CERAM LITE-CAST B". The FDA issued a decision of Substantially Equivalent on February 28, 1980. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Williams Gold Refining Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1980
- Date Received
- February 20, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Metal, Base
- Device Class
- Class II
- Regulation Number
- 872.3710
- Review Panel
- DE
- Submission Type