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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K925333
Device Name SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
Applicant
ASPEN LABS
P.O. BOX 3936
ENGLEWOOD,  CO  80155
Applicant Contact JANE JOHNSON
Correspondent
ASPEN LABS
P.O. BOX 3936
ENGLEWOOD,  CO  80155
Correspondent Contact JANE JOHNSON
Regulation Number884.4120
Classification Product Code
HGI  
Date Received10/21/1992
Decision Date 09/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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