The following data is part of a premarket notification filed by Bsn Medical, Inc. with the FDA for Bellavar / Custom Seamless Soft (a.k.a. Comtesse).
| Device ID | K131496 |
| 510k Number | K131496 |
| Device Name: | BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) |
| 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 | 2013-05-23 |
| Decision Date | 2013-07-10 |