The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Kitazato Opu Needles.
| Device ID | K162881 |
| 510k Number | K162881 |
| Device Name: | Kitazato OPU Needles |
| Classification | Needle, Assisted Reproduction |
| Applicant | Kitazato Corporation 1-1-8 Shibadaimon, Minato-ku Tokyo, JP 105-0012 |
| Contact | Mari Yazaki |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1 Suite 300 Austin, TX 78746 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-14 |
| Decision Date | 2017-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14580745043706 | K162881 | 000 |
| 04580745041828 | K162881 | 000 |
| 14580745041832 | K162881 | 000 |
| 14580745041849 | K162881 | 000 |
| 14580745041856 | K162881 | 000 |
| 14580303269807 | K162881 | 000 |
| 14580303269814 | K162881 | 000 |
| 14580303269821 | K162881 | 000 |
| 14580303269838 | K162881 | 000 |
| 14580745041818 | K162881 | 000 |
| 14580745041801 | K162881 | 000 |
| 14580745043720 | K162881 | 000 |
| 14580745043737 | K162881 | 000 |
| 14580745041474 | K162881 | 000 |
| 14580745041481 | K162881 | 000 |
| 14580745041498 | K162881 | 000 |
| 14580745041504 | K162881 | 000 |
| 14580745041788 | K162881 | 000 |
| 04580745041798 | K162881 | 000 |
| 14580303269845 | K162881 | 000 |
| 14580303269852 | K162881 | 000 |
| 14580303269869 | K162881 | 000 |
| 14580303269371 | K162881 | 000 |
| 14580303269388 | K162881 | 000 |
| 14580303269395 | K162881 | 000 |
| 14580303269401 | K162881 | 000 |
| 14580303269418 | K162881 | 000 |
| 14580303269425 | K162881 | 000 |
| 14580303269432 | K162881 | 000 |
| 14580303269449 | K162881 | 000 |
| 14580303269364 | K162881 | 000 |
| 14580303269357 | K162881 | 000 |
| 14580303269876 | K162881 | 000 |
| 14580303269883 | K162881 | 000 |
| 14580303269296 | K162881 | 000 |
| 14580303269302 | K162881 | 000 |
| 14580303269319 | K162881 | 000 |
| 14580303269326 | K162881 | 000 |
| 14580303269333 | K162881 | 000 |
| 14580303269340 | K162881 | 000 |
| 14580303269456 | K162881 | 000 |