The following data is part of a premarket notification filed by Products For Medicine with the FDA for I-spouse.
| Device ID | K953089 |
| 510k Number | K953089 |
| Device Name: | I-SPOUSE |
| Classification | Accessory, Surgical Apparel |
| Applicant | PRODUCTS FOR MEDICINE 3722 AVE. SAUSALITO Irvine, CA 92714 |
| Contact | Greg Holland |
| Correspondent | Greg Holland PRODUCTS FOR MEDICINE 3722 AVE. SAUSALITO Irvine, CA 92714 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-10-16 |