The following data is part of a premarket notification filed by Beijing Demax Medical Technology Co., Ltd. with the FDA for Mastro Plus Balloon In-deflation Device.
| Device ID | K140943 |
| 510k Number | K140943 |
| Device Name: | MASTRO PLUS BALLOON IN-DEFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. 7TH FLOOR, JINGUI BUSINESS BUILDING, NO 982, CONGYUN ROAD BAIYUN DISTRICT Guangzhou, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. 7TH FLOOR, JINGUI BUSINESS BUILDING, NO 982, CONGYUN ROAD BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06943718223092 | K140943 | 000 |
| 16943718223259 | K140943 | 000 |
| 16943718223266 | K140943 | 000 |
| 16943718223273 | K140943 | 000 |
| 16943718223280 | K140943 | 000 |
| 16943718223297 | K140943 | 000 |
| 06943718206033 | K140943 | 000 |
| 06943718206064 | K140943 | 000 |
| 06943718223047 | K140943 | 000 |
| 06943718223054 | K140943 | 000 |
| 06943718223085 | K140943 | 000 |
| 16943718223242 | K140943 | 000 |