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510(k) K951300

Device
NEZHAT-DORSEY THERMAL RETENTION SYSTEM
Applicant
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC.
510(k) number
K951300
Product code
LHC  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-20
Date received
1995-03-22
Regulation
890.5950
Classification name
Warmer, Irrigation Solution
Medical specialty
Physical Medicine
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTINE D SCHNEIDER
Address
430 Commerce Dr. Delray Beach FL US 33445 33445

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153713Getinge Series Warming CabinetGetinge Sourcing, LLC2016-06-07
K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.2016-01-15
K150190IntraTemp Solution WarmerEcolab, Inc.2015-02-26
K142173NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPEEcolab, Inc.2014-12-30
K142080NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTEDEcolab, Inc.2014-08-28
K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLC2009-01-13
K080609SWC/DWC WARMING CABINETSMac Medical2008-06-13
K051819C CHANGE SOLUTION WARMERC Change Surgical, LLC2005-08-15
K023282ORS-3000LDO.R. Solutions, Inc.2002-11-13
K0232831075LD HUSH-SLUSHO.R. Solutions, Inc.2002-11-13
K021288ORS-1000LDO.R. Solutions, Inc.2002-06-27
K021289WARMER 2000LDO.R. Solutions, Inc.2002-06-26
K002859SSW-STERILE SOLUTION WARMERKmi Kolster Methods, Inc.2000-11-16
K965136UROSURGE UROTHERM FLUID WARMING SYSTEMPrinceton Regulatory Assoc.1998-10-16
K971117WARMETTEOlympic Medical Corp.1997-08-22

Legacy Summary#

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FDA Review#

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