The following data is part of a premarket notification filed by Bsn Medical, Inc. with the FDA for Elvarex/elvarex Soft/elvarex Soft Seamless.
| Device ID | K123561 |
| 510k Number | K123561 |
| Device Name: | ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | BSN MEDICAL, INC. 100 BEIERSDORF DRIVE Rutherford College, NC 28671 |
| Contact | Carroll D Hoyle |
| Correspondent | Carroll D Hoyle BSN MEDICAL, INC. 100 BEIERSDORF DRIVE Rutherford College, NC 28671 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2012-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059993700806 | K123561 | 000 |