The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for Mwo-202 3d Hydraulic Coarse/fine Micromanipulator.
Device ID | K002850 |
510k Number | K002850 |
Device Name: | MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR |
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 | 2000-09-13 |
Decision Date | 2000-10-05 |