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 |