The following data is part of a premarket notification filed by Martin Mclane Medical with the FDA for Hypotrans Model 750.
| Device ID | K911577 |
| 510k Number | K911577 |
| Device Name: | HYPOTRANS MODEL 750 |
| Classification | Container, Transport, Kidney |
| Applicant | MARTIN MCLANE MEDICAL 7317 EL CAJON BLVD. SUITE 201 La Mesa, CA 91941 |
| Contact | Debra Mcquillen |
| Correspondent | Debra Mcquillen MARTIN MCLANE MEDICAL 7317 EL CAJON BLVD. SUITE 201 La Mesa, CA 91941 |
| Product Code | KDK |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1992-07-08 |