The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd with the FDA for Self-destruction Safety Syringes For Single Use; Sterile Hypodermic Syringes For Single Use; Sterile Hypodermic Needles For Single Use; Sterile Safety Hypodermic Needles For Single Use.
| Device ID | K180417 |
| 510k Number | K180417 |
| Device Name: | Self-destruction Safety Syringes For Single Use; Sterile Hypodermic Syringes For Single Use; Sterile Hypodermic Needles For Single Use; Sterile Safety Hypodermic Needles For Single Use |
| Classification | Syringe, Antistick |
| 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 | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-15 |
| Decision Date | 2018-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784698212 | K180417 | 000 |
| 00616784698113 | K180417 | 000 |
| 00616784698038 | K180417 | 000 |