510(k) K012156
K012156 is an FDA 510(k) premarket notification submitted by Wieland Edelmetalle GmbH & Co. for the device "IMAGINE H.E.". The FDA issued a decision of Substantially Equivalent on August 16, 2001. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Wieland Edelmetalle GmbH & Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2001
- Date Received
- July 11, 2001
- 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