The following data is part of a premarket notification filed by Med Lab Products with the FDA for Disposiquet A Dispos. Tourniquet.
Device ID | K840489 |
510k Number | K840489 |
Device Name: | DISPOSIQUET A DISPOS. TOURNIQUET |
Classification | Tourniquet, Nonpneumatic |
Applicant | MED LAB PRODUCTS 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 | 1984-02-06 |
Decision Date | 1984-03-12 |