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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, abortion unit, vacuum
510(k) Number K904248
Device Name MODEL GLASE 210 HOLMIUM LASER SYSTEM
Applicant
CHARLES L. ROSE AND CO., INC.
1963 ROCK STREET, SUITE 17
MOUNTAIN VIEW,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
CHARLES L. ROSE AND CO., INC.
1963 ROCK STREET, SUITE 17
MOUNTAIN VIEW,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.5070
Classification Product Code
HGF  
Date Received09/17/1990
Decision Date 12/14/1990
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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