The following data is part of a premarket notification filed by Djo, Llc with the FDA for Aircast Venaflow Elite System.
| Device ID | K130722 |
| 510k Number | K130722 |
| Device Name: | AIRCAST VENAFLOW ELITE SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DJO, LLC 1430 DECISION STREET Vista, CA 92081 -8553 |
| Contact | Lorri Trotter |
| Correspondent | Lorri Trotter DJO, LLC 1430 DECISION STREET Vista, CA 92081 -8553 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-06-20 |
| Summary: | summary |