The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Lympha-flow(lf1200).
Device ID | K160178 |
510k Number | K160178 |
Device Name: | Lympha-Flow(LF1200) |
Classification | Massager, Powered Inflatable Tube |
Applicant | DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si, KR 15809 |
Contact | Jae-wha Lee |
Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-27 |
Decision Date | 2017-01-11 |
Summary: | summary |