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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 K874837
Device Name KTP/532 LASER FOR OB-GYN USE
Applicant
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Applicant Contact RICHARD P RUDY
Correspondent
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Correspondent Contact RICHARD P RUDY
Regulation Number884.4550
Classification Product Code
HHR  
Date Received11/24/1987
Decision Date 03/14/1988
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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