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510(k) K101606

Device
MICROMED PD-8K INSULATION DEFECT DETECTOR
Applicant
MCGAN TECHNOLOGY, LLC
510(k) number
K101606
Product code
HFG  
Decision
Substantially Equivalent (SESE)
Decision date
2010-10-01
Date received
2010-06-08
Regulation
884.4160
Classification name
Coagulator, Laparoscopic, Unipolar (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JACK GANIS
Address
410 Ridge Rd. Middletown CT US 06457 06457

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HFG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181124Acessa ProVu SystemAcessa Health, Inc.2018-09-28
K132744ACESSA GUIDANCE SYSTEMHalt Medical, Inc.2014-05-27
K132184ACESSA GUIDANCE HANDPIECEHalt Medical, Inc.2014-04-28
K121858THE ABLATION SYSTEMHalt Medical, Inc.2012-11-05
K991424INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.1999-07-22
K961695ENDO-TECH LTD., TIPSRatio Design Lab1996-07-01
K921405DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIPDavol, Inc.1994-03-25
K915406DAVOL ELECTROSUGICAL PROBESDavol, Inc.1992-02-28
K904240SINGLE USE LAPARSCOPIC ELECTRODEAspen Labs1991-02-19
K902555AMCATH COAGULATION PROBEIntl. Medical, Inc.1990-06-20

Legacy Summary#

summary

FDA Review#

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