Baxter Acetone-Alcohol Prep Pads, Sterile
FDA 510(k) K893958 · Span-America Medical Systems, Inc.
510(k) numberK893958
Submission
- Device name
- Baxter Acetone-Alcohol Prep Pads, Sterile
- Applicant
- Span-America Medical Systems, Inc.
Greenville, SC, US - Received
- June 1, 1989
- Decision date
- October 3, 1989
- 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 |
| K892193 | Quickpad (Alcohol Swabs)LKB · Traditional | Holtsch Co., Inc. | 08/04/1989SE |
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| K960188 | Pressureguard: SelectcareFNM · Traditional | 10/02/1996SE |
| K961502 | Lubricating Jelly, Low ViscosityKMJ · Traditional | 07/18/1996SE |
| K961159 | Powered Low Air Loss Mattress SystemFNM · Traditional | 06/14/1996SE |
| K960620 | Pressureguard: Low Air Loss Mattress SystemFNM · Traditional | 04/25/1996SE |
| K960189 | Gel-T CushionKIC · Traditional | 02/07/1996SE |
| K954766 | Pressure Guard Alternating Pressure MattressFNM · Traditional | 01/11/1996SE |
| K953503 | Pressureguard IVFNM · Traditional | 10/24/1995SE |
| K954117 | Customcare Seating SystemKIC · Traditional | 10/13/1995SE |
Questions and answers
When was Baxter Acetone-Alcohol Prep Pads, Sterile cleared by the FDA?
Baxter Acetone-Alcohol Prep Pads, Sterile (K893958) received a 510(k) decision of Substantially Equivalent on October 3, 1989, 124 days after the submission was received.
What is the product code of K893958?
The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.