Alcohol Swabs
FDA 510(k) K833993 · Concord Laboratories, Inc.
510(k) numberK833993
Submission
- Device name
- Alcohol Swabs
- Applicant
- Concord Laboratories, Inc.
Mchenry, IL, US - Received
- November 21, 1983
- Decision date
- January 30, 1984
- 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 |
|---|---|---|
| K883840 | Dri-Vent Arterial Blood Sampling KitLKB · Traditional | 05/16/1989SESD |
| K871825 | Meconium Suction CatheterBSY · Traditional | 06/29/1987SE |
| K864535 | Tracheobronchial Suction Catheter, Cat. No. 6110BSY · Traditional | 01/06/1987SE |
| K862039 | Concord Care Tray · Traditional | 07/03/1986SESD |
| K854601 | Spring Guide Catheter Anesthesia Conduction CathBSO · Traditional | 01/10/1986SE |
| K854327 | Subcutaneous Tunneling Needles & HandlesGCB · Traditional | 11/13/1985SE |
| K851134 | Regional Anesthesia TraysCAZ · Traditional | 07/15/1985SESD |
| K842095 | Epidural TraysCAZ · Traditional | 07/03/1984SE |
| K841486 | Arterial Blood Sampling KitsCBT · Traditional | 05/23/1984SE |
| K840987 | Vaporized HeparinCBT · Traditional | 04/05/1984SE |
Questions and answers
When was Alcohol Swabs cleared by the FDA?
Alcohol Swabs (K833993) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 70 days after the submission was received.
What is the product code of K833993?
The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.