The following data is part of a premarket notification filed by Steridyne Corp. with the FDA for Winter Head Dressing.
| Device ID | K801458 |
| 510k Number | K801458 |
| Device Name: | WINTER HEAD DRESSING |
| Classification | Bandage, Elastic |
| Applicant | STERIDYNE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-24 |
| Decision Date | 1980-07-28 |