The following data is part of a premarket notification filed by Alba-waldensian, Inc. with the FDA for Albahealth C.a.l.m. Sleeve, Model 59001.
| Device ID | K020592 |
| 510k Number | K020592 |
| Device Name: | ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | ALBA-WALDENSIAN, INC. 425 NORTH GATEWAY AVE. Rockwood, TN 37854 |
| Contact | David Bowman |
| Correspondent | David Bowman ALBA-WALDENSIAN, INC. 425 NORTH GATEWAY AVE. Rockwood, TN 37854 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-22 |
| Decision Date | 2002-04-03 |
| Summary: | summary |