510(k) K153130
K153130 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "Initial LiSi Block". The FDA issued a decision of Substantially Equivalent on September 13, 2016. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. GC America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2016
- Date Received
- October 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type