The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Skil-care Super-soft Limb Restraints.
| Device ID | K792012 |
| 510k Number | K792012 |
| Device Name: | SKIL-CARE SUPER-SOFT LIMB RESTRAINTS |
| Classification | Restraint, Protective |
| Applicant | SKIL-CARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-05 |
| Decision Date | 1979-10-26 |