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510(k) K860961

Device
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
Applicant
H & P INDUSTRIES, INC.
510(k) number
K860961
Product code
LKB  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-09
Date received
1986-03-13
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
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH DUNN
Address
9640 S 60th St. Franklin WI US 53132 53132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K112791SITESCRUB IPA DEVICEC. R. Bard2012-02-24
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
K893958BAXTER ACETONE-ALCOHOL PREP PADS, STERILESpan-America Medical Systems, Inc.1989-10-03
K894791BAXTER ACETONE-ALCOHOL SWABSTICK, 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
K852235STERETS INJECTION SWABEllis Pharmaceutical Consulting, Inc.1985-06-07

Legacy Summary#

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FDA Review#

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