One Time Acetone/Alcohol;Swab Sticks
FDA 510(k) K833141 · Acme United Corp.
510(k) numberK833141
Submission
- Device name
- One Time Acetone/Alcohol;Swab Sticks
- Applicant
- Acme United Corp.
Mchenry, IL, US - Received
- September 14, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKB – Pad, Alcohol, Device Disinfectant
- Device class
- Unclassified
Other 510(k)s with product code LKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132380 | Prevantics Device SwabLKB · Traditional | Professional Disposables International, Inc. | 08/27/2014SE |
| K121655 | BD Alcohol SwabLKB · Traditional | Becton, Dickinson & CO | 03/20/2013SE |
| K112791 | Sitescrub Ipa DeviceLKB · Traditional | C. R. Bard | 02/24/2012SE |
| K912161 | I.V. Starr KitLKB · Traditional | Medical Device Inspection Co., Inc. | 10/08/1991SE |
| K912731 | Steri-SwabLKB · Traditional | Westlock Investments (Usa), Inc. | 10/02/1991SE |
| K910735 | Hexidis Alcohol SwabLKB · Traditional | Specialites Septodont | 04/02/1991SE |
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | Bowen & Company, Inc. | 04/04/1990SE |
| K896835 | Alcohol Prep and Povidone-Iodine PrepLKB · Traditional | Norpak Mfg., Inc. | 01/11/1990SE |
| K894791 | Baxter Acetone-Alcohol Swabstick, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
| K893958 | Baxter Acetone-Alcohol Prep Pads, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
More from Span-America Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961323 | Lyofoam Extra C Odor Absorbing Wound DressingKMF · Traditional | 06/19/1996SE |
| K961452 | Lyofoam Extra 'A' Sterile Adhesive Wound DressingKMF · Traditional | 05/31/1996SE |
| K952565 | Lyofoam ExtraKMF · Traditional | 11/14/1995SN |
| K895764 | Modified Lyofoam Wound DressingsKMF · Traditional | 09/10/1990SN |
| K871740 | Lyosheet Surgical Sheet for BurnsFPY · Traditional | 06/09/1987SE |
| K864084 | Lyofoam C Odor-Absorbing DressingFRO · Traditional | 11/21/1986SN |
| K860085 | Lyofoam Wound DressingsNAD · Traditional | 06/27/1986SN |
| K860818 | One Time Enteral Feeding BagKNT · Traditional | 05/15/1986SE |
| K861015 | One Time Hyperal & Catheter Dressing Change TraysFOZ · Traditional | 04/22/1986SE |
| K842186 | Acu-Derm Transparent Wound DressingNAD · Traditional | 08/24/1984SE |
Questions and answers
When was One Time Acetone/Alcohol;Swab Sticks cleared by the FDA?
One Time Acetone/Alcohol;Swab Sticks (K833141) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 47 days after the submission was received.
What is the product code of K833141?
The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.