The following data is part of a premarket notification filed by Intera Corp. with the FDA for Reusable Adult Incontinent Diaper.
Device ID | K883787 |
510k Number | K883787 |
Device Name: | REUSABLE ADULT INCONTINENT DIAPER |
Classification | Garment, Protective, For Incontinence |
Applicant | INTERA CORP. P.O. BOX 25376 Chattanooga, TN 37422 -5376 |
Contact | Larry English |
Correspondent | Larry English INTERA CORP. P.O. BOX 25376 Chattanooga, TN 37422 -5376 |
Product Code | EYQ |
CFR Regulation Number | 876.5920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-07 |
Decision Date | 1988-11-07 |