The following data is part of a premarket notification filed by Nutec Med, Inc. with the FDA for Pressure-quet Tourniquet.
Device ID | K822553 |
510k Number | K822553 |
Device Name: | PRESSURE-QUET TOURNIQUET |
Classification | Tourniquet, Nonpneumatic |
Applicant | NUTEC MED, 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 | 1982-08-24 |
Decision Date | 1982-09-17 |