The following data is part of a premarket notification filed by Manan Medical Devices with the FDA for Manan Tabar-rothschild Galactography Kit.
| Device ID | K881671 |
| 510k Number | K881671 |
| Device Name: | MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MANAN MEDICAL DEVICES 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Contact | Manfred Mittermeier |
| Correspondent | Manfred Mittermeier MANAN MEDICAL DEVICES 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1988-06-15 |