The following data is part of a premarket notification filed by Hunan Vathin Medical Instrument Co., Ltd. with the FDA for Single-use Flexible Rhinolaryngoscope.
Device ID | K221581 |
510k Number | K221581 |
Device Name: | Single-Use Flexible Rhinolaryngoscope |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, CN 411100 |
Contact | Du Jing |
Correspondent | Du Jing Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, CN 411100 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-06-01 |
Decision Date | 2022-11-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06972197480801 | K221581 | 000 |
06972197480795 | K221581 | 000 |
06972197480788 | K221581 | 000 |
06972197480771 | K221581 | 000 |
06972197480580 | K221581 | 000 |
06972197480481 | K221581 | 000 |
06972197480467 | K221581 | 000 |
06972197480405 | K221581 | 000 |