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 |