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510(k) K953953

Device
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
Applicant
DEROYAL INDUSTRIES, INC.
510(k) number
K953953
Product code
KCY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-29
Date received
1995-08-22
Regulation
878.5910
Classification name
Tourniquet, Pneumatic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MITZI Y SHEARER
Address
200 Debusk Ln. Powell TN US 37849 37849

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.2021-05-20
K162365T-CuffTerumobct, Inc.2017-02-16
K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.2013-08-09
K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLC2011-10-17
K071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.2007-06-07
K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.2005-09-02
K012632TOURNIQUET CUFF; PNEUMATIC TOURNIQUETMedical Instruments Technology, Inc.2001-10-26
K955552EXPRESSAIRE TORUNIQUET SYSTEMSmith & Nephew Richards, Inc.1996-01-05
K954201BUONAFEDE PNEUMATIC SLEEVEPromedic, Inc.1995-11-09
K954103TOURNI-COMPScandinavian Medical JW AB1995-11-01
K952038CLEAN-CUFFInstrumed, Inc.1995-07-11
K940615ACCUTESTInstrumed, Inc.1995-05-19
K945167DJ MEDICAL PNEUMATIC TOURNIQUETDj Medical, Inc.1995-02-13
K942303TECNADYNE T-CUFFTechnadyne Scientific, Inc.1994-07-20
K933994ARTHREX TOURNIQUET FOR LEG HOLDERArthrex, Inc.1994-03-23

Legacy Summary#

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FDA Review#

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