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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 K863221
Device Name OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
Applicant
LASERSCOPE
3350 SCOTT BLVD., BLDG.30
SANTA CLARA,  CA  95051
Applicant Contact RICHARD P RUDY
Correspondent
LASERSCOPE
3350 SCOTT BLVD., BLDG.30
SANTA CLARA,  CA  95051
Correspondent Contact RICHARD P RUDY
Regulation Number884.4550
Classification Product Code
HHR  
Date Received08/21/1986
Decision Date 03/02/1987
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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