The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Acetone Alcohol Swabs.
Device ID | K833936 |
510k Number | K833936 |
Device Name: | ACETONE ALCOHOL SWABS |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LKB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-15 |
Decision Date | 1984-01-30 |