The following data is part of a premarket notification filed by Kuo Tai Hospital Managements & Consultant Co., Ltd with the FDA for Zirconia Syringe Needle.
| Device ID | K093043 |
| 510k Number | K093043 |
| Device Name: | ZIRCONIA SYRINGE NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD 2F-1, NO.27, TAYOU RD., SONGSHAN DISTRICT Taipei, TW 10585 |
| Contact | Chao-shent Chao |
| Correspondent | Chao-shent Chao KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD 2F-1, NO.27, TAYOU RD., SONGSHAN DISTRICT Taipei, TW 10585 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-08-20 |