The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for Im-9b Microinjectors.
| Device ID | K001912 |
| 510k Number | K001912 |
| Device Name: | IM-9B MICROINJECTORS |
| 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 | 2000-06-23 |
| Decision Date | 2000-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04589818020012 | K001912 | 000 |