The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Permagum.
Device ID | K771627 |
510k Number | K771627 |
Device Name: | PERMAGUM |
Classification | Material, Impression |
Applicant | ESPE GMBH (US) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-08-26 |
Decision Date | 1977-09-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERMAGUM 73087173 1056414 Dead/Expired |
ESPE FABRIK PHARM. PRAPARATE GMBH 1976-05-14 |
PERMAGUM 71527181 0508383 Live/Registered |
PRESSTITE ENGINEERING COMPANY, THE 1947-07-05 |
PERMAGUM 71400996 0356814 Live/Registered |
PRESSITITE ENGINEERING COMPANY 1937-12-17 |