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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)
510(k) Number K101606
Device Name MICROMED PD-8K INSULATION DEFECT DETECTOR
Applicant
Mcgan Technology, LLC
410 Ridge Rd.
Middletown,  CT  06457
Applicant Contact JACK GANIS
Correspondent
Mcgan Technology, LLC
410 Ridge Rd.
Middletown,  CT  06457
Correspondent Contact JACK GANIS
Regulation Number884.4160
Classification Product Code
HFG  
Date Received06/08/2010
Decision Date 10/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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