The following data is part of a premarket notification filed by Tianjin Medis Medical Device Co., Ltd. with the FDA for Disposable Endotracheal Tube, Sterile, Accucuff.
| Device ID | K160694 |
| 510k Number | K160694 |
| Device Name: | Disposable Endotracheal Tube, Sterile, AccuCuff |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | TIANJIN MEDIS MEDICAL DEVICE CO., LTD. 10-A TIANZHI INDUSTRIAL CENTER, NO. 12 HONG YUAN ROAD Tianjin City, CN 300385 |
| Contact | Zhenchuang Yang |
| Correspondent | Mike Gu OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD LEVEL 7, JIN GUI BUSINESS CENTER, 982 CUNYUN ROAD, BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-14 |
| Decision Date | 2017-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16920687301478 | K160694 | 000 |
| 16920687300976 | K160694 | 000 |
| 16920687300983 | K160694 | 000 |
| 16920687300990 | K160694 | 000 |
| 16920687301003 | K160694 | 000 |
| 16920687301027 | K160694 | 000 |
| 16920687301416 | K160694 | 000 |
| 16920687301430 | K160694 | 000 |
| 16920687301454 | K160694 | 000 |
| 16920687300969 | K160694 | 000 |