The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsafe(r) Pre-filled Normal Saline Flush Syringe.
| Device ID | K183473 |
| 510k Number | K183473 |
| Device Name: | AMSafe(R) Pre-Filled Normal Saline Flush Syringe |
| Classification | Saline, Vascular Access Flush |
| Applicant | Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Contact | Jim Barley |
| Correspondent | Jim Barley Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10704411010005 | K183473 | 000 |
| 30704411013512 | K183473 | 000 |
| 40704411013502 | K183473 | 000 |
| 30704411013499 | K183473 | 000 |
| 40704411013489 | K183473 | 000 |
| 40704411013472 | K183473 | 000 |
| 40704411016640 | K183473 | 000 |
| 40704411016633 | K183473 | 000 |
| 40704411016626 | K183473 | 000 |
| 40704411016619 | K183473 | 000 |
| 40704411016602 | K183473 | 000 |
| 40704411013526 | K183473 | 000 |
| 20680651486503 | K183473 | 000 |
| 10704411009993 | K183473 | 000 |
| 10704411009986 | K183473 | 000 |
| 10704411009979 | K183473 | 000 |
| 30704411009966 | K183473 | 000 |
| 30704411009959 | K183473 | 000 |
| 00704411009941 | K183473 | 000 |
| 00704411009934 | K183473 | 000 |
| 20680651486534 | K183473 | 000 |
| 20680651486527 | K183473 | 000 |
| 30680651486517 | K183473 | 000 |
| 40704411016596 | K183473 | 000 |