The following data is part of a premarket notification filed by Zhejiang Kindley Medical Devices Co.,ltd with the FDA for Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle With Holder, Safety Blood Collecting Needle With Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set With Holder, Safety Blood Collecting Set.
| Device ID | K172763 |
| 510k Number | K172763 |
| Device Name: | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle With Holder, Safety Blood Collecting Needle With Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set With Holder, Safety Blood Collecting Set |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Zhejiang Kindley Medical Devices Co.,Ltd No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District Wenzhou, CN 325025 |
| Contact | Yong Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, CN 325025 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-13 |
| Decision Date | 2018-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850048235014 | K172763 | 000 |
| 40612479244458 | K172763 | 000 |
| 40612479244472 | K172763 | 000 |
| 10085002813107 | K172763 | 000 |
| 10085002813114 | K172763 | 000 |
| 10085002813121 | K172763 | 000 |
| 10085002813138 | K172763 | 000 |
| 10085002813145 | K172763 | 000 |
| 10085002813152 | K172763 | 000 |
| 10850028131098 | K172763 | 000 |
| 10850028131081 | K172763 | 000 |
| 10850028131074 | K172763 | 000 |
| 00850048235021 | K172763 | 000 |
| 10850028131005 | K172763 | 000 |
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| 10850028131036 | K172763 | 000 |
| 10850028131043 | K172763 | 000 |
| 10850028131050 | K172763 | 000 |
| 10850028131067 | K172763 | 000 |
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| 20304040132382 | K172763 | 000 |
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| 40612479258844 | K172763 | 000 |
| 40612479244342 | K172763 | 000 |
| 40612479244373 | K172763 | 000 |
| 40612479244403 | K172763 | 000 |
| 40612479244434 | K172763 | 000 |
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| 10085002813183 | K172763 | 000 |
| 10085002813190 | K172763 | 000 |
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| 10850028131128 | K172763 | 000 |
| 10850028131135 | K172763 | 000 |
| 10850028131142 | K172763 | 000 |
| 10850028131159 | K172763 | 000 |
| 40612479244533 | K172763 | 000 |