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510(k) K033591

Device
REPROCESSED TROCARS
Applicant
CLEAR MEDICAL, INC.
510(k) number
K033591
Product code
KBG  
Decision
Substantially Equivalent (SESE)
Decision date
2005-06-03
Date received
2003-11-13
Regulation
874.4420
Classification name
Trocar, Sinus
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MIKE KOVACS
Address
1776 136th Pl. NE Bellevue WA US 98005 98005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KBG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013987REPROCESSED DISPOSABLE TROCARSAdven Medical2002-03-01
K844186CONTINENT STOMA SYSTEM & ACCESSORIESChesebrough-Pond'S U.S.A. Co.1985-01-15

Legacy Summary#

summary

FDA Review#

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