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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, surgical, gynecologic
510(k) Number K772023
Device Name OB/GYN LASER, MODEL 920
Original Applicant
Regulation Number884.4550
Classification Product Code
Date Received10/21/1977
Decision Date 11/18/1977
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No