The following data is part of a premarket notification filed by Kronner Prototypes, Inc. with the FDA for Kronner Side-kick Uterine Manipulator Holder.
| Device ID | K130758 |
| 510k Number | K130758 |
| Device Name: | KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97471 |
| Contact | Richard F Kronner, M.d. |
| Correspondent | Richard F Kronner, M.d. KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97471 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2013-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856589007080 | K130758 | 000 |