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510(k) K945590

Device
SCOPETEX(TM)
Applicant
SMITH HELMS MULLISS & MOORE, L.L.P.
510(k) number
K945590
Product code
CCW  
Decision
Substantially Equivalent (SESE)
Decision date
1997-05-20
Date received
1994-11-14
Regulation
868.5540
Classification name
Laryngoscope, Rigid
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHRISTINE T NERO
Address
Post Office Box 21927 Greensboro NC US 27420 27420

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.2019-08-02
K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLC2017-06-22
K140951YEESCOPE LARYNGOSCOPESYeescope Pty. , Ltd.2014-11-10
K121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.2012-06-21
K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETNovamed, LLC2007-02-09
K062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.2006-11-17
K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, Inc.2006-08-31
K062231MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001Minrad, Inc.2006-08-31
K041852MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002Minrad, Inc.2004-11-15
K984101FLEXIBLADEArco Medic , Ltd.1999-09-03
K971377GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPEWilson Greatbatch Technologies, Inc.1998-04-30
K970619GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLEWilson Greatbatch Technologies, Inc.1997-11-19
K961832BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVERBlue Ridge Medical, Inc.1996-09-06
K945301LARYNGOSCOPE COVERSotiria Mourkidou, M.D.1996-05-31
K954787ILLUMINATORHospitak, Inc.1996-01-31

Legacy Summary#

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FDA Review#

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