The following data is part of a premarket notification filed by Hospital Specialty Co. with the FDA for At Ease Adult Diaper.
| Device ID | K880455 |
| 510k Number | K880455 |
| Device Name: | AT EASE ADULT DIAPER |
| Classification | Garment, Protective, For Incontinence |
| Applicant | HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland, OH 44103 -4896 |
| Contact | Robert A May |
| Correspondent | Robert A May HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland, OH 44103 -4896 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-02 |
| Decision Date | 1988-04-14 |