The following data is part of a premarket notification filed by Shenzhen Ant Hi-tech Industrial Co., Ltd with the FDA for Pressure Connecting Tube.
Device ID | K131770 |
510k Number | K131770 |
Device Name: | PRESSURE CONNECTING TUBE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD 46 Keji Ave.,Yuquan Industrial Park, Fenggang Dongguan, CN 523696 |
Contact | Lynn Fu |
Correspondent | Lynn Fu SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD 46 Keji Ave.,Yuquan Industrial Park, Fenggang Dongguan, CN 523696 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-17 |
Decision Date | 2014-02-26 |
Summary: | summary |