The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Endo C Brush.
| Device ID | K882628 |
| 510k Number | K882628 |
| Device Name: | ENDO C BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Contact | Milgrom |
| Correspondent | Milgrom MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-07-25 |