The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for Mn-4 Coarse Manipulator.
Device ID | K010298 |
510k Number | K010298 |
Device Name: | MN-4 COARSE MANIPULATOR |
Classification | Micromanipulators And Microinjectors, Assisted Reproduction |
Applicant | NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagaya-ku, Tokyo, JP 157-0062 |
Contact | Mitsuko Yoneyama |
Correspondent | Mitsuko Yoneyama NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagaya-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 | 2001-01-31 |
Decision Date | 2001-03-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04589818020043 | K010298 | 000 |