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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ent microsurgical carbon-dioxide
510(k) Number K864975
Device Name LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
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 Number874.4500
Classification Product Code
EWG  
Date Received12/22/1986
Decision Date 02/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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