The following data is part of a premarket notification filed by Amsino International Inc. with the FDA for Amsure Sterile Water, And Sterile Normal Saline For Wound Flush.
| Device ID | K181423 |
| 510k Number | K181423 |
| Device Name: | AMSure Sterile Water, And Sterile Normal Saline For Wound Flush |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40704411010365 | K181423 | 000 |
| 00704411010350 | K181423 | 000 |
| 00704411007459 | K181423 | 000 |
| 00704411007442 | K181423 | 000 |