The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Skil-care Bed Rail Pads.
Device ID | K791993 |
510k Number | K791993 |
Device Name: | SKIL-CARE BED RAIL PADS |
Classification | Bed, Manual |
Applicant | SKIL-CARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-03 |
Decision Date | 1979-10-26 |