The following data is part of a premarket notification filed by Ob/gyn Concepts, Ltd. with the FDA for The Ob-gyn Concepts Vaginal Aspirator.
| Device ID | K863610 |
| 510k Number | K863610 |
| Device Name: | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR |
| Classification | Instrument, Manual, General Obstetric-gynecologic |
| Applicant | OB/GYN CONCEPTS, LTD. 613 DOCK DR. Barrington, IL 60010 |
| Contact | Charles B Root |
| Correspondent | Charles B Root OB/GYN CONCEPTS, LTD. 613 DOCK DR. Barrington, IL 60010 |
| Product Code | KOH |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-16 |
| Decision Date | 1987-01-07 |