The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Ambeze Disposable Incontinence Pants.
| Device ID | K840753 |
| 510k Number | K840753 |
| Device Name: | AMBEZE DISPOSABLE INCONTINENCE PANTS |
| Classification | Garment, Protective, For Incontinence |
| Applicant | IPCO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-13 |