The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsafe Neuflo Needleless Connector.
| Device ID | K220267 |
| 510k Number | K220267 |
| Device Name: | AMSafe NeuFlo Needleless Connector |
| Classification | Set, Administration, Intravascular |
| Applicant | Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Contact | Jane Gao |
| Correspondent | Jane Gao Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-10-07 |