The following data is part of a premarket notification filed by Professional Products, Inc. with the FDA for Marlene Stockings & Tights.
| Device ID | K954295 |
| 510k Number | K954295 |
| Device Name: | MARLENE STOCKINGS & TIGHTS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | PROFESSIONAL PRODUCTS, INC. 6727 STOUT RD. Memphis, TN 38119 |
| Contact | Margaret J Kime |
| Correspondent | Margaret J Kime PROFESSIONAL PRODUCTS, INC. 6727 STOUT RD. Memphis, TN 38119 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1995-11-08 |