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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K162466
Device Name LuminScan (TM) Imaging System
Applicant
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd.
Nanjing,  CN 210032
Applicant Contact Becky Li
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd.
Nanjing,  CN 210032
Correspondent Contact Becky Li
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received09/02/2016
Decision Date 11/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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