510(k) K090434
K090434 is an FDA 510(k) premarket notification submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO for the device "BECE PRESS". The FDA issued a decision of Substantially Equivalent on July 6, 2009. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2009
- Date Received
- February 19, 2009
- 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