The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Jansen-anderson Insemination Set.
Device ID | K914150 |
510k Number | K914150 |
Device Name: | JANSEN-ANDERSON INSEMINATION SET |
Classification | Cannula, Intrauterine Insemination |
Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Contact | Michelle Young |
Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Product Code | MFD |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-16 |
Decision Date | 1992-09-02 |