QUICKPAD (ALCOHOL SWABS)
FDA 510(k) clearance K892193 · decided 1989-08-04
Clearance details
- K-number
- K892193
- Device name
- QUICKPAD (ALCOHOL SWABS)
- Applicant
- Holtsch Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-05
- Decision date
- 1989-08-04
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- LKB
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Califon, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PREVANTICS DEVICE SWAB (K132380) | Professional Disposables International, Inc. | 2014-08-27 |
| BD ALCOHOL SWAB (K121655) | Becton, Dickinson & CO | 2013-03-20 |
| SITESCRUB IPA DEVICE (K112791) | C. R. Bard | 2012-02-24 |
| I.V. STARR KIT (K912161) | Medical Device Inspection Co., Inc. | 1991-10-08 |
| STERI-SWAB (K912731) | Westlock Investments (Usa), Inc. | 1991-10-02 |
| HEXIDIS ALCOHOL SWAB (K910735) | Specialites Septodont | 1991-04-02 |
| BOWEN ELECTRODE SKIN PREPATORY CLEANSER (K896898) | Bowen & Company, Inc. | 1990-04-04 |
| ALCOHOL PREP AND POVIDONE-IODINE PREP (K896835) | Norpak Mfg., Inc. | 1990-01-11 |
| BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (K893958) | Span-America Medical Systems, Inc. | 1989-10-03 |
| BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE (K894791) | Span-America Medical Systems, Inc. | 1989-10-03 |
| DRI-VENT ARTERIAL BLOOD SAMPLING KIT (K883840) | Concord Laboratories, Inc. | 1989-05-16 |
| PRE-MOISTENED CLEANSING PAD (K890514) | Bausch & Lomb, Inc. | 1989-04-10 |
Recalls involving this device
No recalls on record reference this clearance.