The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Skil-care Turn And Hold Pad.
Device ID | K792318 |
510k Number | K792318 |
Device Name: | SKIL-CARE TURN AND HOLD PAD |
Classification | Device, Transfer, Patient, Manual |
Applicant | SKIL-CARE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMR |
CFR Regulation Number | 880.6785 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1979-12-20 |