The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Barrett's Esophageal Cytology Device.
| Device ID | K984168 |
| 510k Number | K984168 |
| Device Name: | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE |
| Classification | Instrument, Biopsy, Mechanical, Gastrointestinal |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Dean Secrest |
| Correspondent | Dean Secrest UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | FCF |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-20 |
| Decision Date | 1999-12-07 |
| Summary: | summary |