The following data is part of a premarket notification filed by Insight Medical Corp. with the FDA for Femassist Urinary Device.
| Device ID | K963858 |
| 510k Number | K963858 |
| Device Name: | FEMASSIST URINARY DEVICE |
| Classification | External Urethral Occluder, Urinary Incontinence-control, Female |
| Applicant | INSIGHT MEDICAL CORP. 580 MAIN ST. Bolton, MA 01740 |
| Contact | Robert W Schaefer |
| Correspondent | Robert W Schaefer INSIGHT MEDICAL CORP. 580 MAIN ST. Bolton, MA 01740 |
| Product Code | MNG |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-10-21 |
| Summary: | summary |