The following data is part of a premarket notification filed by Medifactia Ab with the FDA for Transit-pellets.
| Device ID | K181760 |
| 510k Number | K181760 |
| Device Name: | Transit-Pellets |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | Medifactia AB Sahlgrenska Science Park Medicinaregatan 8A Gothenburg, SE Se-413 90 |
| Contact | Diana Nystrom |
| Correspondent | Connie Qiu M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, NY 10018 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2019-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350099550010 | K181760 | 000 |