The following data is part of a premarket notification filed by Acme United Corp. with the FDA for One Time Acetone/alcohol;swab Sticks.
Device ID | K833141 |
510k Number | K833141 |
Device Name: | ONE TIME ACETONE/ALCOHOL;SWAB STICKS |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | ACME UNITED CORP. 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 | 1983-09-14 |
Decision Date | 1983-10-31 |