The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Injection Needle.
Device ID | K150434 |
510k Number | K150434 |
Device Name: | Injection Needle |
Classification | Endoscopic Injection Needle, Gastroenterology-urology |
Applicant | Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
Contact | Becky Li |
Correspondent | Becky Li Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
Product Code | FBK |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-19 |
Decision Date | 2015-06-02 |
Summary: | summary |