The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Fms Vue Fluid Managment System, Fms Connect Interface Cable.
| Device ID | K130169 |
| 510k Number | K130169 |
| Device Name: | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE |
| Classification | Arthroscope |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-24 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705020485 | K130169 | 000 |
| 10886705020478 | K130169 | 000 |
| 10886705020591 | K130169 | 000 |