The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Microgyn Ii Elec Stim Device Treat Of Urin Inconti.
| Device ID | K891773 |
| 510k Number | K891773 |
| Device Name: | MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Jerome A Saxon |
| Correspondent | Jerome A Saxon HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-08-23 |