The following data is part of a premarket notification filed by Johnson & Johnson Consumer Products, Inc. with the FDA for Serenity Contoured Absorbent Shields.
| Device ID | K840679 |
| 510k Number | K840679 |
| Device Name: | SERENITY CONTOURED ABSORBENT SHIELDS |
| Classification | Garment, Protective, For Incontinence |
| Applicant | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-03-22 |