The following data is part of a premarket notification filed by Eppendorf Ag with the FDA for Transferman 4m Micromanipulator.
Device ID | K142207 |
510k Number | K142207 |
Device Name: | TransferMan 4m Micromanipulator |
Classification | Micromanipulators And Microinjectors, Assisted Reproduction |
Applicant | EPPENDORF AG BARKHANSENWEG 1 Hamburg, DE 22339 |
Contact | Cornelia Hildebrandt |
Correspondent | Jo Anne Bronikowski APTIV SOLUTIONS 62 Forest Street Suite 300 Marlborough, MA 01752 |
Product Code | MQJ |
CFR Regulation Number | 884.6150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-11 |
Decision Date | 2015-01-23 |
Summary: | summary |