Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K182635 |
Device Name |
Signal Catheter |
Applicant |
Safe Medical Design |
2722 Fulton Street |
San Francisco,
CA
94118
|
|
Applicant Contact |
Raymond "Buzz" Bonneau |
Correspondent |
AcKnowledge Regulatory Strategies, LLC |
2251 San Diego Avenue, Suite B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Allison Komiyama |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/24/2018 |
Decision Date | 01/10/2019 |
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
|
|
|