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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 K875314
Device Name GL-35 COLPOSCOPIC LASER SYSTEM
Applicant
Laser Engineering, Inc.
113 Cedar St.
Milford,  MA  01757
Applicant Contact ROBERT I RUDKO
Correspondent
Laser Engineering, Inc.
113 Cedar St.
Milford,  MA  01757
Correspondent Contact ROBERT I RUDKO
Regulation Number884.4550
Classification Product Code
HHR  
Date Received12/29/1987
Decision Date 08/05/1988
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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