The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Alvue Balloon Dilation System.
| Device ID | K171939 |
| 510k Number | K171939 |
| Device Name: | ALVUE Balloon Dilation System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Globus Medical, Inc. 2560 General Armistead Ave. Valley Forge Business Center Audubon, PA 19403 |
| Contact | Lori Burns |
| Correspondent | Lori Burns Globus Medical, Inc. 2560 General Armistead Ave. Valley Forge Business Center Audubon, PA 19403 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2018-03-07 |
| Summary: | summary |