The following data is part of a premarket notification filed by Cimed Intl., Inc. with the FDA for Surgical Vessel Dilators-catheriza-.
Device ID | K833676 |
510k Number | K833676 |
Device Name: | SURGICAL VESSEL DILATORS-CATHERIZA- |
Classification | Dilator, Vessel, Surgical |
Applicant | CIMED INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWP |
CFR Regulation Number | 870.4475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-14 |
Decision Date | 1984-03-19 |