The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Petite Basic System 701 Elt.
| Device ID | K131420 |
| 510k Number | K131420 |
| Device Name: | PETITE BASIC SYSTEM 701 ELT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEGO AFEK AC LTD 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Contact | Maria Griffin |
| Correspondent | Maria Griffin MEGO AFEK AC LTD 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2013-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290105871480 | K131420 | 000 |