The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Intrauterine Hemostasis Balloon Stent.
| Device ID | K863439 |
| 510k Number | K863439 |
| Device Name: | INTRAUTERINE HEMOSTASIS BALLOON STENT |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Byron Wickett |
| Correspondent | Byron Wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-05 |
| Decision Date | 1987-06-02 |