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 |