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510(k) K211814

Wellead Endoscopic Seal by Well Lead Medical Co., Ltd. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2022
Date Received
June 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

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