The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Phlebo Press Dvt 603.
Device ID | K142772 |
510k Number | K142772 |
Device Name: | Phlebo Press DVT 603 |
Classification | Sleeve, Limb, Compressible |
Applicant | Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
Contact | Aharon Cohen |
Correspondent | Aharon Cohen Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-25 |
Decision Date | 2014-12-16 |