The following data is part of a premarket notification filed by Glenveigh Surgical, Llc with the FDA for Glenveigh Vaginal Tamponade Balloon Catheter.
| Device ID | K093904 |
| 510k Number | K093904 |
| Device Name: | GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | GLENVEIGH SURGICAL, LLC 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt GLENVEIGH SURGICAL, LLC 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-04-14 |
| Summary: | summary |