The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Introducers.
Device ID | K790034 |
510k Number | K790034 |
Device Name: | INTRODUCERS |
Classification | Introducer, Catheter |
Applicant | CLINCAL INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-03 |
Decision Date | 1979-02-01 |