The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Mrinnervu Disposable Endorectal Cervix Coil#bcr-15.
| Device ID | K930779 |
| 510k Number | K930779 |
| Device Name: | MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. KAPPA MANOR II 271 KAPPA DRIVE Pittsburgh, PA 15238 |
| Contact | John E Stevens |
| Correspondent | John E Stevens MEDRAD, INC. KAPPA MANOR II 271 KAPPA DRIVE Pittsburgh, PA 15238 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1993-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10616258009305 | K930779 | 000 |