The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for E-cath.
Device ID | K152952 |
510k Number | K152952 |
Device Name: | E-Cath |
Classification | Catheter, Conduction, Anesthetic |
Applicant | PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
Contact | Christian G.h. Quass |
Correspondent | Christian G.h. Quass PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-06 |
Decision Date | 2016-07-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
E-CATH 79294228 not registered Live/Pending |
Pajunk GmbH Medizintechnologie 2020-07-02 |