The following data is part of a premarket notification filed by Aplicare, Inc. with the FDA for Aplicare One Acetone Alcohol Swabstick.
| Device ID | K833183 |
| 510k Number | K833183 |
| Device Name: | APLICARE ONE ACETONE ALCOHOL SWABSTICK |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | APLICARE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1983-10-31 |