The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Anti-embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02.
| Device ID | K090921 |
| 510k Number | K090921 |
| Device Name: | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | BEIERSDORF, INC. 187 DANBURY RD. Wilton, CT 06897 |
| Contact | Peter Stratton |
| Correspondent | Peter Stratton BEIERSDORF, INC. 187 DANBURY RD. Wilton, CT 06897 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-12-18 |
| Summary: | summary |