The following data is part of a premarket notification filed by Baurs Krey Assoc., Inc. with the FDA for Glattelast Compression Stockings.
| Device ID | K841215 |
| 510k Number | K841215 |
| Device Name: | GLATTELAST COMPRESSION STOCKINGS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | BAURS KREY ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-22 |
| Decision Date | 1984-06-07 |