The following data is part of a premarket notification filed by Carolina Narrow Fabric Co. with the FDA for Carolina Narrow Fabric Company Open Toe Anti-embolism Stocking.
| Device ID | K960931 |
| 510k Number | K960931 |
| Device Name: | CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | CAROLINA NARROW FABRIC CO. 1100 PATTERSON AVE. Winston Salem, NC 27101 -1485 |
| Contact | Susan Rooks |
| Correspondent | Susan Rooks CAROLINA NARROW FABRIC CO. 1100 PATTERSON AVE. Winston Salem, NC 27101 -1485 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-07 |
| Decision Date | 1996-05-23 |