The following data is part of a premarket notification filed by Carefusion 2200 Inc. with the FDA for Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula.
| Device ID | K140761 |
| 510k Number | K140761 |
| Device Name: | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | CAREFUSION 2200 INC. 72 N. FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Contact | Jane Weber |
| Correspondent | Jane Weber CAREFUSION 2200 INC. 72 N. FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-04-21 |
| Summary: | summary |