The following data is part of a premarket notification filed by Griffiths And Nielsen Ltd with the FDA for Saphenamedical Anti-embolism Stockings.
| Device ID | K101224 |
| 510k Number | K101224 |
| Device Name: | SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | GRIFFITHS AND NIELSEN LTD STANE STREET, SLINFORD Horsham, West Sussex, GB Rh13 0tw |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay GRIFFITHS AND NIELSEN LTD STANE STREET, SLINFORD Horsham, West Sussex, GB Rh13 0tw |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-12-03 |
| Summary: | summary |