The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd. with the FDA for Safelock Disposable Blood Collection Set, Disposable Blood Collection Set.
| Device ID | K151991 |
| 510k Number | K151991 |
| Device Name: | Safelock Disposable Blood Collection Set, Disposable Blood Collection Set |
| Classification | Set, Administration, Intravascular |
| Applicant | JIANGYIN CAINA TECHNOLOGY CO., LTD. NO.2, TAIFU ROAD, HUASHI TOWN Jiangyin, CN 214421 |
| Contact | Jun Lu |
| Correspondent | Diana Hong 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 | 2015-07-20 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784895222 | K151991 | 000 |
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| 00810008212660 | K151991 | 000 |
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| 10193489010411 | K151991 | 000 |
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| 00810008211878 | K151991 | 000 |