The following data is part of a premarket notification filed by Secol Co. with the FDA for Elastic Bandage.
| Device ID | K802785 |
| 510k Number | K802785 |
| Device Name: | ELASTIC BANDAGE |
| Classification | Bandage, Elastic |
| Applicant | SECOL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-04 |
| Decision Date | 1980-12-11 |