The following data is part of a premarket notification filed by Medi Usa, Lp with the FDA for Medi Butler.
| Device ID | K051324 |
| 510k Number | K051324 |
| Device Name: | MEDI BUTLER |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | MEDI USA, LP 1800 MASSACHUSETTS AVE., N.W. Washington, DC 20036 -1221 |
| Contact | Gary L Yingling |
| Correspondent | Gary L Yingling MEDI USA, LP 1800 MASSACHUSETTS AVE., N.W. Washington, DC 20036 -1221 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-12-05 |
| Summary: | summary |