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 |