The following data is part of a premarket notification filed by Aplicare, Inc. with the FDA for Aplicare Alcohol Prep Pad.
Device ID | K833182 |
510k Number | K833182 |
Device Name: | APLICARE ALCOHOL PREP PAD |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | APLICARE, 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 | 1983-09-19 |
Decision Date | 1983-10-27 |