The following data is part of a premarket notification filed by Hr Pharmaceuticals, Inc. with the FDA for Aquaflate Pre-filled Sterile Water Syringe 10ml.
| Device ID | K200556 |
| 510k Number | K200556 |
| Device Name: | AquaFlate Pre-Filled Sterile Water Syringe 10mL |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | HR Pharmaceuticals, Inc. 2600 Eastern Boulevard, Suite 201 York, PA 17402 |
| Contact | Colby Wiesman |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-03-31 |
| Summary: | summary |