The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Depend Fitted Brief.
| Device ID | K854378 |
| 510k Number | K854378 |
| Device Name: | DEPEND FITTED BRIEF |
| Classification | Garment, Protective, For Incontinence |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Der Wal |
| Correspondent | Der Wal KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-30 |
| Decision Date | 1985-12-02 |