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 |