The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsafe Sure-lok Needle-free Connector.
| Device ID | K173665 |
| 510k Number | K173665 |
| Device Name: | AMSafe Sure-Lok Needle-Free Connector |
| Classification | Set, Administration, Intravascular |
| Applicant | Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Contact | Cathy Hong |
| Correspondent | Cathy Hong 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 | 2017-11-29 |
| Decision Date | 2018-09-05 |