The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Pressure Biofeedback Vaginal Pressure Probe And Anal Pressure Probe.
| Device ID | K013653 |
| 510k Number | K013653 |
| Device Name: | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE |
| Classification | Perineometer |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Cindy Roberts |
| Correspondent | Cindy Roberts HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-03-05 |
| Summary: | summary |