The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Manipulator & Injector, Uterine.
| Device ID | K770727 |
| 510k Number | K770727 |
| Device Name: | MANIPULATOR & INJECTOR, UTERINE |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-19 |
| Decision Date | 1977-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937013232 | K770727 | 000 |
| 20888937013195 | K770727 | 000 |