Hexidis Alcohol Swab
FDA 510(k) K910735 · Specialites Septodont
510(k) numberK910735
Submission
- Device name
- Hexidis Alcohol Swab
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- February 21, 1991
- Decision date
- April 2, 1991
- 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 |
| 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 |
| K892193 | Quickpad (Alcohol Swabs)LKB · Traditional | Holtsch Co., Inc. | 08/04/1989SE |
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| K915467 | Cimpat S Dental CementEMA · Traditional | 02/03/1992SE |
| K915466 | Septopack Temporary FillingEBG · Traditional | 02/03/1992SE |
| K913573 | Safety Plus Dental Injection NeedleDZM · Traditional | 11/07/1991SE |
| K913572 | Autopack Non-Eugenol Periodontal DressingEMA · Traditional | 10/09/1991SE |
Questions and answers
When was Hexidis Alcohol Swab cleared by the FDA?
Hexidis Alcohol Swab (K910735) received a 510(k) decision of Substantially Equivalent on April 2, 1991, 40 days after the submission was received.
What is the product code of K910735?
The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.