The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Venaflow System, Model 30a.
Device ID | K992454 |
510k Number | K992454 |
Device Name: | VENAFLOW SYSTEM, MODEL 30A |
Classification | Sleeve, Limb, Compressible |
Applicant | AIRCAST, INC. 92 RIVER RD. Summit, NJ 07902 |
Contact | Stephen Kenney |
Correspondent | Stephen Kenney AIRCAST, INC. 92 RIVER RD. Summit, NJ 07902 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-23 |
Decision Date | 2000-01-13 |