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510(k) K910449

Device
Prestitch
Applicant
CRANTEC CO.
510(k) number
K910449
Product code
KCY
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-29
Date received
1991-01-29
Regulation
878.5910
Classification name
Tourniquet, Pneumatic
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD CRANGLE
Address
120 Sports Mall Plz. 5505 South 900 E. Salt Lake City UT US 84117 84117

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K953953DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFFDeroyal Industries, Inc.1995-09-29
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