The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Adult Incontinence Brief.
Device ID | K834296 |
510k Number | K834296 |
Device Name: | ADULT INCONTINENCE BRIEF |
Classification | Garment, Protective, For Incontinence |
Applicant | PROCTER & GAMBLE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EYQ |
CFR Regulation Number | 876.5920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-08 |
Decision Date | 1984-02-04 |