The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Stovall Endometrial Brush.
| Device ID | K911620 |
| 510k Number | K911620 |
| Device Name: | STOVALL ENDOMETRIAL BRUSH |
| Classification | Brush, Endometrial |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1994-06-24 |