The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Orbit Galaxy G2 Microcoil Delivery System.
| Device ID | K120686 |
| 510k Number | K120686 |
| Device Name: | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Kim Fonda |
| Correspondent | Kim Fonda Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-06 |
| Decision Date | 2012-04-04 |
| Summary: | summary |