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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K962653
Device Name MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
Applicant
Microgyn Corp.
125 John Hancock Rd.
Taunton,  MA  02780
Applicant Contact CRAIG TRAUB
Correspondent
Microgyn Corp.
125 John Hancock Rd.
Taunton,  MA  02780
Correspondent Contact CRAIG TRAUB
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
KNS  
Date Received07/08/1996
Decision Date 02/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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