The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Underpad, Disposable Polypropy. (unilux).
| Device ID | K760164 |
| 510k Number | K760164 |
| Device Name: | UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) |
| Classification | Garment, Protective, For Incontinence |
| Applicant | PARKE-DAVIS CO. 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 | 1976-07-06 |
| Decision Date | 1976-07-20 |