The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Cytology Brush.
| Device ID | K924104 |
| 510k Number | K924104 |
| Device Name: | CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Marlin Younker |
| Correspondent | Marlin Younker UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1992-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995183773 | K924104 | 000 |