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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
510(k) Number K855146
Device Name LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
Applicant
Laserscope
3350 Scott Blvd., Bldg.30
Santa Clara,  CA  95051
Applicant Contact ROSS ERICKSON
Correspondent
Laserscope
3350 Scott Blvd., Bldg.30
Santa Clara,  CA  95051
Correspondent Contact ROSS ERICKSON
Regulation Number874.4490
Classification Product Code
LMS  
Date Received12/24/1985
Decision Date 04/11/1986
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
Predetermined Change
Control Plan Authorized		 No
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