The following data is part of a premarket notification filed by Lifeglobal Group, Llc with the FDA for Lifeglobal Micro Tips.
Device ID | K152581 |
510k Number | K152581 |
Device Name: | LifeGlobal Micro Tips |
Classification | Microtools, Assisted Reproduction (pipettes) |
Applicant | LifeGlobal Group, LLC 393 Soundview Road Guilford, CT 06437 |
Contact | Michael D. Cecchi |
Correspondent | Michael D. Cecchi LifeGlobal Group, LLC 393 Soundview Road Guilford, CT 06437 |
Product Code | MQH |
CFR Regulation Number | 884.6130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-10 |
Decision Date | 2016-04-11 |