The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Pre-filled Syringe For Balloon Inflation With Sterile Water.
| Device ID | K181814 |
| 510k Number | K181814 |
| Device Name: | AMSure Pre-filled Syringe For Balloon Inflation With Sterile Water |
| Classification | Catheter, Retention Type, Balloon |
| 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 | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-09-04 |
| Summary: | summary |