The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Dolphin 3 Fluid Management System.
| Device ID | K110852 |
| 510k Number | K110852 |
| Device Name: | DOLPHIN 3 FLUID MANAGEMENT SYSTEM |
| Classification | Insufflator, Hysteroscopic |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham Baillie |
| Correspondent | Graham Baillie GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-28 |
| Decision Date | 2011-07-19 |
| Summary: | summary |