The following data is part of a premarket notification filed by Millennium Medical Technologies Inc (dba Cellmyx) with the FDA for Intellifat Disposable Adipose Tissue Harvesting And Transfer Kit, Intellifat Body On Demand (bod) Kit.
Device ID | K210528 |
510k Number | K210528 |
Device Name: | IntelliFat Disposable Adipose Tissue Harvesting And Transfer Kit, IntelliFat Body On Demand (BOD) Kit |
Classification | System, Suction, Lipoplasty |
Applicant | Millennium Medical Technologies Inc (DBA Cellmyx) 6352 Corte De Abeto, Suite A Carlsbad, CA 92011 |
Contact | Wangzhong Sheng |
Correspondent | Jacqueline Hauge Cellmyx 37743 175th Avenue Avon, MN 56310 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-23 |
Decision Date | 2022-03-16 |