Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K152050 |
Device Name |
Pencylcap |
Applicant |
B. BRAUN MELSUNGEN AG |
CARL-BRAUN STRASSE 1 |
MELSUNGEN,
DE
34212
|
|
Applicant Contact |
HANS-ULRICH GAUDIN |
Correspondent |
YES MEDICAL DEVICE SERVICES GMBH |
BAHNSTRASSE 42-46 |
FRIEDRICHSDORF,
DE
61381
|
|
Correspondent Contact |
KARIN LUBBERS |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 07/23/2015 |
Decision Date | 03/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|