The following data is part of a premarket notification filed by Advanced Equipment Development, Inc. with the FDA for Kidney Perfusion Machine.
| Device ID | K864140 |
| 510k Number | K864140 |
| Device Name: | KIDNEY PERFUSION MACHINE |
| Classification | System, Perfusion, Kidney |
| Applicant | ADVANCED EQUIPMENT DEVELOPMENT, INC. 73 KERCHEVAL STE. 201 Grosse Pte Farms, MI 48236 |
| Contact | Wayne G Wegner |
| Correspondent | Wayne G Wegner ADVANCED EQUIPMENT DEVELOPMENT, INC. 73 KERCHEVAL STE. 201 Grosse Pte Farms, MI 48236 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1987-03-05 |