The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Mrinnervu Disposable Endorectal Colon Coil, Catalong No. Pcc-15.
| Device ID | K952232 |
| 510k Number | K952232 |
| Device Name: | MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Rodney J Rylands |
| Correspondent | Rodney J Rylands MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-06-26 |