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 |