Device Classification Name |
Catheter, Straight
|
510(k) Number |
K202566 |
Device Name |
Wiygul Catheter |
Applicant |
Big Blue Biotech, Inc. |
690 Canton Street, Suite 302 |
Westwood,
MA
02090
|
|
Applicant Contact |
Russ Olsen |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/04/2020 |
Decision Date | 09/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|