The following data is part of a premarket notification filed by Paul Hartmann Corp. with the FDA for Molinea Incontinent Pad.
| Device ID | K843404 |
| 510k Number | K843404 |
| Device Name: | MOLINEA INCONTINENT PAD |
| Classification | Garment, Protective, For Incontinence |
| Applicant | PAUL HARTMANN CORP. P.O. BOX 1161 Greenwood , SC 29646 - |
| Contact | Robert L Crawford |
| Correspondent | Robert L Crawford PAUL HARTMANN CORP. P.O. BOX 1161 Greenwood , SC 29646 - |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-30 |
| Decision Date | 1984-10-19 |