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 | K182003 |
| 510k Number | K182003 |
| 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,Consultant P.O. Box 4414 (A109) 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 | 2018-07-26 |
| Decision Date | 2019-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290105879110 | K182003 | 000 |