The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for 3d Hdraulic Fine Micromanipulator Mo-188ne.
Device ID | K001131 |
510k Number | K001131 |
Device Name: | 3D HDRAULIC FINE MICROMANIPULATOR MO-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 |