The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Aircast Edemaflow System.
| Device ID | K933977 |
| 510k Number | K933977 |
| Device Name: | AIRCAST EDEMAFLOW SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | AIRCAST, INC. P.O. BOX 709 92 RIVER ROAD Summit, NJ 07902 -0709 |
| Contact | Glenn W Johnson, Jr. |
| Correspondent | Glenn W Johnson, Jr. 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 | 1993-08-13 |
| Decision Date | 1993-12-07 |