The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Skil-care Gel Wedge, Flotation Pad.
| Device ID | K801217 |
| 510k Number | K801217 |
| Device Name: | SKIL-CARE GEL WEDGE, FLOTATION PAD |
| Classification | Cushion, Flotation |
| Applicant | SKIL-CARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-21 |
| Decision Date | 1980-05-30 |