The following data is part of a premarket notification filed by Circon Video with the FDA for Dolphin Ii Fluid Management System, Model Dol-2.
| Device ID | K011876 |
| 510k Number | K011876 |
| Device Name: | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | CIRCON VIDEO 492 OLD CONNECTICUT PATH Framingham, MA 01701 -4584 |
| Contact | John Delucia |
| Correspondent | John Delucia CIRCON VIDEO 492 OLD CONNECTICUT PATH Framingham, MA 01701 -4584 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-15 |
| Decision Date | 2002-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925001770 | K011876 | 000 |