Device Classification Name |
system, perfusion, kidney
|
510(k) Number |
K203262 |
Device Name |
Cannula for Organ Perfusion |
Applicant |
Bridge to Life Ltd. |
128 Suber Rd., Suite A |
Columbia,
SC
29210
|
|
Applicant Contact |
Brett Schultz |
Correspondent |
Wood Burditt Group |
10 E Scranton Ave, Ste 201 |
Lake Bluff,
IL
60044
|
|
Correspondent Contact |
H Carl Jenkins |
Regulation Number | 876.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/05/2020 |
Decision Date | 07/01/2021 |
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
|
|
|