The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Single-use Patient Underpad.
| Device ID | K862348 |
| 510k Number | K862348 |
| Device Name: | SINGLE-USE PATIENT UNDERPAD |
| Classification | Bedding, Disposable, Medical |
| Applicant | PROCTER & GAMBLE MFG. CO. P.O. BOX 599 Cincinnati, OH 45201 |
| Contact | James T O'reilly |
| Correspondent | James T O'reilly PROCTER & GAMBLE MFG. CO. P.O. BOX 599 Cincinnati, OH 45201 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-20 |
| Decision Date | 1986-07-02 |