The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Contimed Ii Biofeedback Dev Treat Of Urin Inconti.
Device ID | K891774 |
510k Number | K891774 |
Device Name: | CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI |
Classification | Perineometer |
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 | HIR |
CFR Regulation Number | 884.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-24 |
Decision Date | 1989-08-23 |