The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for The Advance Catheter For Hsg And Sis.
| Device ID | K123258 |
| 510k Number | K123258 |
| Device Name: | THE ADVANCE CATHETER FOR HSG AND SIS |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CATHETER RESEARCH, INC. 5610 W 82ND ST Indianapolis, IN 46278 |
| Contact | Babacar Diouf |
| Correspondent | Babacar Diouf CATHETER RESEARCH, INC. 5610 W 82ND ST Indianapolis, IN 46278 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-18 |
| Decision Date | 2013-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852073002224 | K123258 | 000 |
| 10852073002217 | K123258 | 000 |
| 10852073002200 | K123258 | 000 |