The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for Im-6 Microinjector.
Device ID | K003304 |
510k Number | K003304 |
Device Name: | IM-6 MICROINJECTOR |
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 | 2000-10-20 |
Decision Date | 2000-11-22 |