The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for Central Vein Catherization Tray Cc-20.
Device ID | K834073 |
510k Number | K834073 |
Device Name: | CENTRAL VEIN CATHERIZATION TRAY CC-20 |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PACKAGING TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-25 |
Decision Date | 1984-02-28 |