The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Amcath Disposable Cytology Brush.
| Device ID | K923200 |
| 510k Number | K923200 |
| Device Name: | AMCATH DISPOSABLE CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Contact | Peter H Wettermann |
| Correspondent | Peter H Wettermann INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1992-12-07 |