The following data is part of a premarket notification filed by Primeline Industries, Inc. with the FDA for Tourniquet/latex Tourniquet.
Device ID | K830467 |
510k Number | K830467 |
Device Name: | TOURNIQUET/LATEX TOURNIQUET |
Classification | Tourniquet, Nonpneumatic |
Applicant | PRIMELINE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAX |
CFR Regulation Number | 878.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-15 |
Decision Date | 1983-03-31 |