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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 K912046
Device Name SINGLE USE LEE 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 Received05/08/1991
Decision Date 03/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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