The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co.,ltd. with the FDA for Inflation Device.
| Device ID | K170027 |
| 510k Number | K170027 |
| Device Name: | Inflation Device |
| Classification | Syringe, Balloon Inflation |
| Applicant | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai, CN 201803 |
| Contact | Xu Jianhai |
| Correspondent | Jeffery Hui SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai, CN 201803 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004162040 | K170027 | 000 |
| 26950900920039 | K170027 | 000 |
| 26950900920015 | K170027 | 000 |