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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K052599
Device Name 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
Applicant
SUZHOU 66 VISION TECH CO., LTD.
600/8/503 LIUZHOU ROAD
SHANGHAI,  CN 200233
Applicant Contact GONG BO
Correspondent
SUZHOU 66 VISION TECH CO., LTD.
600/8/503 LIUZHOU ROAD
SHANGHAI,  CN 200233
Correspondent Contact GONG BO
Regulation Number886.1570
Classification Product Code
HLJ  
Subsequent Product Code
HLL  
Date Received09/21/2005
Decision Date 11/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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