The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for 3d Manual Coarse Manipulator Mn-188ne.
| Device ID | K001130 |
| 510k Number | K001130 |
| Device Name: | 3D MANUAL COARSE MANIPULATOR MN-188NE |
| Classification | Micromanipulators And Microinjectors, Assisted Reproduction |
| Applicant | NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagay-ku, Tokyo, JP 157-0062 |
| Contact | Mitsuko Yoneyama |
| Correspondent | Mitsuko Yoneyama NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagay-ku, Tokyo, JP 157-0062 |
| Product Code | MQJ |
| CFR Regulation Number | 884.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-04-21 |