The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Lympha Press 201max, Model 201max.
| Device ID | K100677 |
| 510k Number | K100677 |
| Device Name: | LYMPHA PRESS 201MAX, MODEL 201MAX |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEGO AFEK AC LTD 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava 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 | 2010-03-10 |
| Decision Date | 2010-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290105870155 | K100677 | 000 |