SHIRT, MITTEN CUFF INFANT
Device Facts
| Record ID | K760360 |
|---|---|
| Device Name | SHIRT, MITTEN CUFF INFANT |
| Applicant | Precept, Inc. |
| Product Code | FME · General Hospital |
| Decision Date | Oct 20, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6265 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.
