The following data is part of a premarket notification filed by Rsh Llc with the FDA for Rsh Biliary Stone Removal Device.
| Device ID | K131642 |
| 510k Number | K131642 |
| Device Name: | RSH BILIARY STONE REMOVAL DEVICE |
| Classification | Dislodger, Stone, Biliary |
| Applicant | RSH LLC 5121 FEAGAN ST. Houston, TX 77007 |
| Contact | Amy Springs |
| Correspondent | Amy Springs RSH LLC 5121 FEAGAN ST. Houston, TX 77007 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2013-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405006411 | K131642 | 000 |
| 10653405006404 | K131642 | 000 |