BED SHEET, PILLOW CASE
Device Facts
| Record ID | K884380 |
|---|---|
| Device Name | BED SHEET, PILLOW CASE |
| Applicant | Saybrex Intl., Inc. |
| Product Code | KME · General Hospital |
| Decision Date | Nov 8, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6060 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.
