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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 St.
Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Charles L. Rose and Co., Inc.
1963 Rock St.
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
Predetermined Change
Control Plan Authorized		 No
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