The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for Uterine Manipulator/injector.
| Device ID | K974357 |
| 510k Number | K974357 |
| Device Name: | UTERINE MANIPULATOR/INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | John A Steen, Ph.d. |
| Correspondent | John A Steen, Ph.d. 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 | 1997-11-19 |
| Decision Date | 1998-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852073002712 | K974357 | 000 |
| 10852073002637 | K974357 | 000 |
| 10852073002514 | K974357 | 000 |