The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Comfysleeve 1-75 And Lymphapod Sleeves, For Use With Lp Optimal And Plus.
| Device ID | K100521 |
| 510k Number | K100521 |
| Device Name: | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEGO AFEK AC LTD 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Avaha Stein |
| Correspondent | Avaha Stein MEGO AFEK AC LTD 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 | 2010-02-23 |
| Decision Date | 2010-05-14 |
| Summary: | summary |