The following data is part of a premarket notification filed by Jiangsu Caina Technology Co., Ltd. with the FDA for Disposable Insulin Pen Needle.
| Device ID | K170846 |
| 510k Number | K170846 |
| Device Name: | Disposable Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Jiangsu Caina Technology Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214425 |
| Contact | Jun Lu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-21 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00373317000125 | K170846 | 000 |
| 50885380194069 | K170846 | 000 |
| 50885380194076 | K170846 | 000 |
| 50885380194083 | K170846 | 000 |
| 50885380194090 | K170846 | 000 |
| 00373317000033 | K170846 | 000 |
| 00373317000026 | K170846 | 000 |
| 00373317000057 | K170846 | 000 |
| 00373317000040 | K170846 | 000 |
| 00373317000071 | K170846 | 000 |
| 00373317000088 | K170846 | 000 |
| 00373317000101 | K170846 | 000 |
| 00373317000095 | K170846 | 000 |
| 00373317000149 | K170846 | 000 |
| 00373317000118 | K170846 | 000 |
| 50885380194052 | K170846 | 000 |