The following data is part of a premarket notification filed by Intera Corp. with the FDA for Intera Shield And Intera Undergarment.
| Device ID | K885185 |
| 510k Number | K885185 |
| Device Name: | INTERA SHIELD AND INTERA UNDERGARMENT |
| 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 | 1988-12-14 |
| Decision Date | 1989-02-08 |