The following data is part of a premarket notification filed by Edge Medical Llc with the FDA for Erb Endorectal Balloon.
| Device ID | K141958 |
| 510k Number | K141958 |
| Device Name: | ERB ENDORECTAL BALLOON |
| Classification | Prostate Immobilizer Rectal Balloon |
| Applicant | EDGE MEDICAL LLC 3924 CASCADE BEACH RD. Lutsen, MN 55612 |
| Contact | Gregory Mathison |
| Correspondent | Gregory Mathison EDGE MEDICAL LLC 3924 CASCADE BEACH RD. Lutsen, MN 55612 |
| Product Code | PCT |
| CFR Regulation Number | 892.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-18 |
| Decision Date | 2014-11-18 |
| Summary: | summary |