The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Angiography Needle W/wo Connection.
Device ID | K840923 |
510k Number | K840923 |
Device Name: | ANGIOGRAPHY NEEDLE W/WO CONNECTION |
Classification | Introducer, Catheter |
Applicant | DLP, INC. 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 | 1984-03-02 |
Decision Date | 1984-04-17 |