Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K031151 |
Device Name |
TS3 TUBING SET |
Applicant |
GLOBAL BLOOD RESOURCES, LLC |
998 WINDSOR AVE. |
WINDSOR,
CT
06095
|
|
Applicant Contact |
KEITH SAMOLYK |
Correspondent |
GLOBAL BLOOD RESOURCES, LLC |
998 WINDSOR AVE. |
WINDSOR,
CT
06095
|
|
Correspondent Contact |
KEITH SAMOLYK |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 04/10/2003 |
Decision Date | 06/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|