The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for Uterine Injector.
| Device ID | K020292 |
| 510k Number | K020292 |
| Device Name: | UTERINE INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | John A Steen |
| Correspondent | John A Steen CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852073002623 | K020292 | 000 |
| 10852073002538 | K020292 | 000 |
| 10852073002521 | K020292 | 000 |
| 10852073002088 | K020292 | 000 |