The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for Im-11 Pneumatic Microinjector.
Device ID | K113712 |
510k Number | K113712 |
Device Name: | IM-11 PNEUMATIC MICROINJECTOR |
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 | 2011-12-19 |
Decision Date | 2012-03-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04589818020050 | K113712 | 000 |