The following data is part of a premarket notification filed by Dafoe & Dafoe, Inc. with the FDA for Incontinence Pad Or Adult Diaper.
| Device ID | K820961 |
| 510k Number | K820961 |
| Device Name: | INCONTINENCE PAD OR ADULT DIAPER |
| Classification | Garment, Protective, For Incontinence |
| Applicant | DAFOE & DAFOE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-06 |
| Decision Date | 1982-04-16 |