The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Lympha Press Optimal Plus.
Device ID | K170658 |
510k Number | K170658 |
Device Name: | Lympha Press Optimal Plus |
Classification | Sleeve, Limb, Compressible |
Applicant | Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
Contact | Reuven Yunger |
Correspondent | Ilan Sharon Ilan Sharon A 109 Neot Golf Caesarea, IL 3088900 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-03 |
Decision Date | 2017-05-31 |