The following data is part of a premarket notification filed by Mps Medical, Inc. with the FDA for Bd Univia Rightfit Enteral Extension Sets And Transitional Adapters.
| Device ID | K200082 |
| 510k Number | K200082 |
| Device Name: | BD Univia RightFit Enteral Extension Sets And Transitional Adapters |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | MPS Medical, Inc. 830 Challenger Street, Suite 200 Brea, CA 92821 |
| Contact | Barry Kazemi |
| Correspondent | Paul Gasser MPS Medical, Inc. 830 Challenger Street, Suite 200 Brea, CA 92821 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-15 |
| Decision Date | 2020-07-30 |