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510(k) K052599

66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A by Suzhou 66 Vision Tech Co., Ltd. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2006
Date Received
September 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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