The following data is part of a premarket notification filed by Qlrad International Ltd. with the FDA for Rectalpro 75 Endorectal Balloon.
| Device ID | K180478 |
| 510k Number | K180478 |
| Device Name: | RectalPro 75 Endorectal Balloon |
| Classification | Prostate Immobilizer Rectal Balloon |
| Applicant | QLRAD International Ltd. Wormerweg 6 Almere, NL 1311 Xb |
| Contact | Arjen Winkel |
| Correspondent | Audrey Swearingen Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | PCT |
| CFR Regulation Number | 892.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2018-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719326258218 | K180478 | 000 |
| 08719326258287 | K180478 | 000 |
| 08719326258256 | K180478 | 000 |