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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K170446
Device Name LT-300 SD Digital Video Colposcope
Applicant
Lutech Industries, Inc.
105 Remington Blvd.
Suite C
Ronkonkoma,  NY  11779
Applicant Contact Leanna Vachula
Correspondent
Lee & Xiao
2600 Mission St.
Suite 100
San Marino,  CA  91108
Correspondent Contact Jimmy Wu
Regulation Number884.1630
Classification Product Code
HEX  
Date Received02/14/2017
Decision Date 05/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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