The following data is part of a premarket notification filed by Kitazato Medical Co., Ltd. with the FDA for Kitazato Opu Needle.
| Device ID | K112462 |
| 510k Number | K112462 |
| Device Name: | KITAZATO OPU NEEDLE |
| Classification | Needle, Assisted Reproduction |
| Applicant | KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-26 |
| Decision Date | 2012-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14580303269173 | K112462 | 000 |
| 14580303269098 | K112462 | 000 |
| 14580303269104 | K112462 | 000 |
| 14580303269111 | K112462 | 000 |
| 14580303269128 | K112462 | 000 |
| 14580303269135 | K112462 | 000 |
| 14580303269142 | K112462 | 000 |
| 14580303269159 | K112462 | 000 |
| 14580303269166 | K112462 | 000 |
| 14580303269081 | K112462 | 000 |