The following data is part of a premarket notification filed by Pluromed, Inc. with the FDA for Backstop And Backstop Injector.
| Device ID | K090430 |
| 510k Number | K090430 |
| Device Name: | BACKSTOP AND BACKSTOP INJECTOR |
| Classification | Dissolvable Gel For Preventing Ureteral Stone Migration |
| Applicant | PLUROMED, INC. 25-H OLYMPIA AVENUE Woburn, MA 01801 |
| Contact | James Wilkie |
| Correspondent | James Wilkie PLUROMED, INC. 25-H OLYMPIA AVENUE Woburn, MA 01801 |
| Product Code | ONJ |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-06-02 |
| Summary: | summary |