The following data is part of a premarket notification filed by Waters Medical Systems, Llc with the FDA for Perf-gen Pulsatile Perfusion Solution.
| Device ID | K121736 |
| 510k Number | K121736 |
| Device Name: | PERF-GEN PULSATILE PERFUSION SOLUTION |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W. Rochester, MN 55901 |
| Contact | Robert Warren |
| Correspondent | Robert Warren WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W. Rochester, MN 55901 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-13 |
| Decision Date | 2013-08-16 |
| Summary: | summary |