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510(k) K935584

Device
MEDNEXT BUR
Applicant
MEDNEXT, INC.
510(k) number
K935584
Product code
EQJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-22
Date received
1993-11-18
Regulation
874.4140
Classification name
Bur, Ear, Nose And Throat
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J MICKEL, PH.D.
Address
3878 Prospect Ave., Suite 24 West Point Beach FL US 33404 33404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EQJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161514Precision Thin Reciprocating Blade, 0.010in.Stryker Corporation2017-01-17
K041985XPS CURVED BURMedtronic Xomed, Inc.2004-08-12
K974232ESSENTIAL SHAVER SYSTEMGyrus Ent LLC1998-01-12
K960853ACE SYSTEMXomed, Inc.1996-04-03
K955704TREBAY MICRODEBRIDER SYSTEMTrebay Medical Corp.1996-01-30
K955294SOF - ABRASION BURTrebay Medical Corp.1995-12-22
K954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)Trebay Medical Corp.1995-12-06
K953370KARL STORZ ENT SHAVERKARL STORZ Endoscopy-America, Inc.1995-09-06
K950337KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILLKARL STORZ Endoscopy-America, Inc.1995-08-23
K952609REDI DRILL DRILL SYSTEMTrebay Medical Corp.1995-07-31
K953096ESSENTIAL SHAVER SYSTEMSmith & Nephew Richards, Inc.1995-07-28
K946332KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATIONKARL STORZ Endoscopy-America, Inc.1995-06-05
K951526TREBAY IRRGATED CUTTER BLADETrebay Medical Corp.1995-05-12
K895738MICROMEDICS EAR, NOSE AND THROAT BURSMicromedics, Inc.1989-12-19
K893499CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASSCmsi1989-11-16

Legacy Summary#

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FDA Review#

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