Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K181760 |
Device Name |
Transit-Pellets |
Applicant |
Medifactia AB |
Sahlgrenska Science Park |
Medicinaregatan 8A |
Gothenburg,
SE
SE-413 90
|
|
Applicant Contact |
Diana Nystrom |
Correspondent |
M Squared Associates, Inc. |
575 8th Avenue, Suite 1212 |
New York,
NY
10018
|
|
Correspondent Contact |
Connie Qiu |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 07/03/2018 |
Decision Date | 08/08/2019 |
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
|
|
|