510(k) K123929
K123929 is an FDA 510(k) premarket notification submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO for the device "BEGOPAL+". The FDA issued a decision of Substantially Equivalent on March 14, 2013. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. 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
- March 14, 2013
- Date Received
- December 20, 2012
- Clearance Type
- Abbreviated
- 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