The following data is part of a premarket notification filed by B. Braun Melsungen Ag with the FDA for Pencylcap.
Device ID | K152050 |
510k Number | K152050 |
Device Name: | Pencylcap |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | B. BRAUN MELSUNGEN AG CARL-BRAUN STRASSE 1 Melsungen, DE 34212 |
Contact | Hans-ulrich Gaudin |
Correspondent | Karin Lubbers YES MEDICAL DEVICE SERVICES GMBH BAHNSTRASSE 42-46 Friedrichsdorf, DE 61381 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-23 |
Decision Date | 2016-03-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PENCYLCAP 90473829 not registered Live/Pending |
MERCK KGAA 2021-01-19 |
PENCYLCAP 79135807 4561924 Live/Registered |
Merck KGaA 2013-07-12 |