SERENITY CONTOURED ABSORBENT SHIELDS
Device Facts
| Record ID | K840679 |
|---|---|
| Device Name | SERENITY CONTOURED ABSORBENT SHIELDS |
| Applicant | Johnson & Johnson Consumer Products, Inc. |
| Product Code | EYQ · Gastroenterology, Urology |
| Decision Date | Mar 22, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5920 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
