The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Tao Brush I.u.m.c. Endometrial Sampler.
| Device ID | K082066 |
| 510k Number | K082066 |
| Device Name: | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER |
| Classification | Brush, Endometrial |
| Applicant | COOK UROLOGICAL, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Cindy Foote |
| Correspondent | Cindy Foote COOK UROLOGICAL, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-22 |
| Decision Date | 2008-11-07 |
| Summary: | summary |