FDA.reportPublic FDA data

510(k) K924538

Device
IV START KIT
Applicant
CML, INC.
510(k) number
K924538
Product code
LRS  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1993-07-02
Date received
1992-09-08
Regulation
880.5200
Classification name
I.v. Start Kit
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH DUNN
Address
P.O. Box 306 817 W. Mohr Ave. Waterford WI US 53185 53185

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050654AMSINO I.V. START KITAmsino International, Inc.2005-05-02
K001879INFUSION IV SETNirvi Intl. USA2001-11-20
K963722IV START KITGrand Medical Products1996-11-27
K951167EMS I.V. START KITEmergency Medical Supply, Inc.1995-05-16
K950184B. BRAUN IV START KITSB. Braun of America, Inc.1995-03-15
K944041PERSONAL HEARING SYSTEMResound Corp.1994-12-27
K943941SAFESTART VASCULAR ACCESS START KITBecton Dickinson Vascular Access, Inc.1994-10-20
K935684IV START KITCush Medical Products1994-06-10
K942238I.V. STARTPAK VASCULAR ACCESS START KITBd Becton Dickinson Vacutainer Systems Preanalytic1994-06-03
K941469IV START KITClinical Resources, Inc.1994-05-12
K925017IV PREP KIT (NON-STERILE)Customed, Inc.1993-08-27
K925018IV PREP KIT W/O DRESSING (NON-STERILE)Customed, Inc.1993-08-27
K933041COLD CD ASP MODULE, ITEElectone, Inc.1993-08-02
K930196CEPTI-SEAL I.V. PREP KITMedi-Flex Hospital Products, Inc.1993-07-02
K923361I.V. START KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.1993-06-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases