The following data is part of a premarket notification filed by Bauerfeind Gmbh & Co. with the FDA for Venotrain Color Compression Stockings & Pantyhose.
| Device ID | K860826 |
| 510k Number | K860826 |
| Device Name: | VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | BAUERFEIND GMBH & CO. 811-D LIVINGSTON COURT Marietta, GA 30067 |
| Contact | George M Mohr |
| Correspondent | George M Mohr BAUERFEIND GMBH & CO. 811-D LIVINGSTON COURT Marietta, GA 30067 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-06-18 |