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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 Rd.
Shanghai,  CN 200233
Applicant Contact GONG BO
Correspondent
Suzhou 66 Vision Tech Co., Ltd.
600/8/503 Liuzhou Rd.
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
Predetermined Change
Control Plan Authorized		 No
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