Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K212444 |
Device Name |
Qora Stool Management Kit |
Applicant |
CM Technologies, Inc. |
2165 San Diego Avenue |
San Diego,
CA
92110
|
|
Applicant Contact |
Nishith Chasmawala |
Correspondent |
Matrix Medical Consulting, Inc. |
8880 Rio San Diego Drive, Suite 800 |
San Diego,
CA
92108
|
|
Correspondent Contact |
Alan Donald |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/05/2021 |
Decision Date | 11/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|