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510(k) K112791

Device
SITESCRUB IPA DEVICE
Applicant
CR BARD
510(k) number
K112791
Product code
LKB  
Decision
Substantially Equivalent (SESE)
Decision date
2012-02-24
Date received
2011-09-26
Regulation
510(k) Premarket Notification
Classification name
Pad, Alcohol, Device Disinfectant
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LYNN M KIRCHOFF
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LKB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132380PREVANTICS DEVICE SWABProfessional Disposables International, Inc.2014-08-27
K121655BD ALCOHOL SWABBecton, Dickinson & CO2013-03-20
K912161I.V. STARR KITMedical Device Inspection Co., Inc.1991-10-08
K912731STERI-SWABWestlock Investments (Usa), Inc.1991-10-02
K910735HEXIDIS ALCOHOL SWABSpecialites Septodont1991-04-02
K896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERBowen & Company, Inc.1990-04-04
K896835ALCOHOL PREP AND POVIDONE-IODINE PREPNorpak Mfg., Inc.1990-01-11
K894791BAXTER ACETONE-ALCOHOL SWABSTICK, STERILESpan-America Medical Systems, Inc.1989-10-03
K893958BAXTER ACETONE-ALCOHOL PREP PADS, STERILESpan-America Medical Systems, Inc.1989-10-03
K892193QUICKPAD (ALCOHOL SWABS)Holtsch Co., Inc.1989-08-04
K883840DRI-VENT ARTERIAL BLOOD SAMPLING KITConcord Laboratories, Inc.1989-05-16
K890514PRE-MOISTENED CLEANSING PADBausch & Lomb, Inc.1989-04-10
K870718AMERICAN ALCOHOL PREP PAD STERILE MEDIUMSpan-America Medical Systems, Inc.1987-05-07
K860961GAMMA RADIATION STERILIZED ALCOHOL PREP PADSH & P Industries, Inc.1986-04-09
K852235STERETS INJECTION SWABEllis Pharmaceutical Consulting, Inc.1985-06-07

Legacy Summary#

summary

FDA Review#

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