The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd with the FDA for Disposable Insulin Syringe.
| Device ID | K162180 |
| 510k Number | K162180 |
| Device Name: | Disposable Insulin Syringe |
| Classification | Syringe, Piston |
| Applicant | BERPU MEDICAL TECHNOLOGY CO., LTD NO.14 XINGJI ROAD, YONGXING STREET, LONGWAN DISTRICT Wenzhou, CN 325000 |
| Contact | Jundong Tan |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-04 |
| Decision Date | 2016-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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