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 |