The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Vestogum.
Device ID | K991221 |
510k Number | K991221 |
Device Name: | VESTOGUM |
Classification | Material, Impression |
Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Andreas Petermann |
Correspondent | Andreas Petermann ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-12 |
Decision Date | 1999-05-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VESTOGUM 73722941 1538849 Dead/Cancelled |
ESPE FABRIK PHARMAZEUTISCHER PRAPARATE GMBH & CO. KG 1988-04-18 |