The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Aircast Venaflow System (modification).
| Device ID | K961676 |
| 510k Number | K961676 |
| Device Name: | AIRCAST VENAFLOW SYSTEM (MODIFICATION) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | AIRCAST, INC. P.O. BOX 709 92 RIVER ROAD Summit, NJ 07902 -0709 |
| Contact | Stephen L Kenney |
| Correspondent | Stephen L Kenney AIRCAST, INC. P.O. BOX 709 92 RIVER ROAD Summit, NJ 07902 -0709 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1997-03-28 |