The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Recovery Pump 737r.
Device ID | K140519 |
510k Number | K140519 |
Device Name: | RECOVERY PUMP 737R |
Classification | Massager, Powered Inflatable Tube |
Applicant | MEGO AFEK AC LTD KIBBUTZ AFEK Afek, IL 30042 |
Contact | Aharon Cohen |
Correspondent | Aharon Cohen MEGO AFEK AC LTD KIBBUTZ AFEK Afek, IL 30042 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-28 |
Decision Date | 2014-06-16 |
Summary: | summary |