The following data is part of a premarket notification filed by Mego Afek with the FDA for Lympha Press Plus Device.
| Device ID | K013331 |
| 510k Number | K013331 |
| Device Name: | LYMPHA PRESS PLUS DEVICE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEGO AFEK BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein MEGO AFEK BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-05 |
| Decision Date | 2001-11-30 |
| Summary: | summary |