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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 K782054
Device Name LASER, CO2 SURGICAL
Original Applicant
CAVITRON CORP.
Regulation Number884.4550
Classification Product Code
HHR  
Date Received12/07/1978
Decision Date 01/17/1979
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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