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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K093639
Device Name SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
Applicant
Huvitz Co., Ltd.
136 W. Orion
Suite 3
Tempe,  AZ  85283
Applicant Contact MATEW J WESS
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/24/2009
Decision Date 12/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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