Device Classification Name |
Tube, Nasogastric
|
510(k) Number |
K142483 |
Device Name |
TurboSEAL Nasogastric Aspiration Tube |
Applicant |
TurboSEAL, L.P. |
7 Haarad St |
Tel Aviv,
IL
6971060
|
|
Applicant Contact |
DORON BESSER |
Correspondent |
DOHMEN LIFE SCIENCE SERVICES, LLC |
11925 W I-70 FRONTAGE ROAD NORTH, SUITE 900 |
WHEAT RIDGE,
CO
80033
|
|
Correspondent Contact |
IAN MARSDEN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/04/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|