The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Protectivstabilizer.
| Device ID | K790186 |
| 510k Number | K790186 |
| Device Name: | PROTECTIVSTABILIZER |
| Classification | Prosthesis, Adhesive, External |
| Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBJ |
| CFR Regulation Number | 878.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-29 |
| Decision Date | 1979-02-26 |