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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 K073190
Device Name SLIT LAMP
Applicant
Huvitz Co., Ltd.
340 Shady Grove Rd.
Flintville,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/13/2007
Decision Date 01/11/2008
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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