The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Endo Dynamics Gastrointestinal Cytology Brush.
| Device ID | K853530 |
| 510k Number | K853530 |
| Device Name: | ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Jack T Berger |
| Correspondent | Jack T Berger E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-23 |
| Decision Date | 1985-10-04 |