510(k) K123929

BEGOPAL+ by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO — Product Code EJH

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