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510(k) K181887

AMD Anti-Fog Solution by Advanced Medical Design Co., Ltd. — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2019
Date Received
July 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

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