The following data is part of a premarket notification filed by Shanghai Kindly Ent. Development Group Co., Ltd. with the FDA for Kdl Disposable Infusion Set.
| Device ID | K112204 |
| 510k Number | K112204 |
| Device Name: | KDL DISPOSABLE INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-01 |
| Decision Date | 2012-09-10 |
| Summary: | summary |