The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Amcath Ureteral Dilators Models 7100,7110,7120.
| Device ID | K894925 |
| 510k Number | K894925 |
| Device Name: | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | INTEC MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Contact | Peter Wettermann |
| Correspondent | Peter Wettermann INTEC MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1989-12-13 |