The following data is part of a premarket notification filed by Shinva Ande Healthcare Apparatus Co.,ltd. with the FDA for Infusion Set For Single Use.
| Device ID | K162601 |
| 510k Number | K162601 |
| Device Name: | Infusion Set For Single Use |
| Classification | Set, Administration, Intravascular |
| Applicant | SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD. NO.77 DEVELOPMENT ZONE NORTH RD Zibo, CN 255086 |
| Contact | Xiaolei Tian |
| Correspondent | Ying Xu MID-LINK CONSULTING CO.,LTD P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20853620005528 | K162601 | 000 |
| 06970440020149 | K162601 | 000 |
| 06970440020163 | K162601 | 000 |
| 06970440020187 | K162601 | 000 |
| 06970440020200 | K162601 | 000 |
| 06970440020224 | K162601 | 000 |
| 06970440020248 | K162601 | 000 |
| 06970440020262 | K162601 | 000 |
| 06970440020286 | K162601 | 000 |
| 06970440020309 | K162601 | 000 |
| 20853620005351 | K162601 | 000 |
| 20853620005368 | K162601 | 000 |
| 06970440020019 | K162601 | 000 |