The following data is part of a premarket notification filed by Myriad Medical, Llc with the FDA for Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301.
| Device ID | K150234 |
| 510k Number | K150234 |
| Device Name: | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 |
| Classification | Prostate Immobilizer Rectal Balloon |
| Applicant | Myriad Medical, LLC 2202 N..West Shore Blvd,Suite 200 Tampa, FL 33607 |
| Contact | Frank Bimbo |
| Correspondent | Frank Bimbo Myriad Medical, LLC 1535 Carrington Court Lawrenceville, GA 30044 |
| Product Code | PCT |
| CFR Regulation Number | 892.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-03-31 |
| Summary: | summary |