The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Practical Compression Device (pcd) 901a&901b.
| Device ID | K121962 |
| 510k Number | K121962 |
| Device Name: | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEGO AFEK AC LTD KIBBUTZ AFEK Afek, IL 30042 |
| Contact | Alex Rapel |
| Correspondent | Alex Rapel MEGO AFEK AC LTD KIBBUTZ AFEK Afek, IL 30042 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-05 |
| Decision Date | 2012-10-19 |