The following data is part of a premarket notification filed by Bego Bremer Goldschlaegerei Wilh. Herbst Gmbh & Co with the FDA for Bece Cad Zirkon Ht+.
Device ID | K132102 |
510k Number | K132102 |
Device Name: | BECE CAD ZIRKON HT+ |
Classification | Powder, Porcelain |
Applicant | BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO WILHELM-HERBST-STRASSE 1 Bremen, DE 28359 |
Contact | Heike Gustke |
Correspondent | Heike Gustke BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO WILHELM-HERBST-STRASSE 1 Bremen, DE 28359 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-08 |
Decision Date | 2013-11-12 |
Summary: | summary |