The following data is part of a premarket notification filed by Renfro Corporation with the FDA for Dr. Scholl's Compression Socks.
| Device ID | K123398 |
| 510k Number | K123398 |
| Device Name: | DR. SCHOLL'S COMPRESSION SOCKS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | RENFRO CORPORATION 661 LINVILLE ROAD Mount Airy, NC 27030 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine RENFRO CORPORATION 661 LINVILLE ROAD Mount Airy, NC 27030 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2012-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00042825534841 | K123398 | 000 |
| 20888625011403 | K123398 | 000 |
| 20888625011397 | K123398 | 000 |
| 20888625001633 | K123398 | 000 |
| 20888625001626 | K123398 | 000 |
| 20888625001619 | K123398 | 000 |
| 20888625001602 | K123398 | 000 |
| 20042825634057 | K123398 | 000 |