The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Tao Brush I.u.m.c. Endometrial Sampler.
| Device ID | K170603 |
| 510k Number | K170603 |
| Device Name: | Tao Brush I.U.M.C. Endometrial Sampler |
| Classification | Brush, Endometrial |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Ian Herman |
| Correspondent | Ian Herman Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-05-24 |
| Summary: | summary |