The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Attends Dispos. Underpad.
Device ID | K853880 |
510k Number | K853880 |
Device Name: | ATTENDS DISPOS. 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 | 1985-09-18 |
Decision Date | 1985-10-16 |