The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Intermittent Pneumatic Compression System.
Device ID | K160180 |
510k Number | K160180 |
Device Name: | Intermittent Pneumatic Compression System |
Classification | Sleeve, Limb, Compressible |
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 | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-27 |
Decision Date | 2016-11-03 |
Summary: | summary |