The following data is part of a premarket notification filed by Aplicare, Inc. with the FDA for Aplicare Three Alcohol Swabsticks.
| Device ID | K833184 |
| 510k Number | K833184 |
| Device Name: | APLICARE THREE ALCOHOL SWABSTICKS |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00653160373851 | K833184 | 000 |