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 |