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510(k) K160170

Lehman Manometry Catheter by Wilson-Cook Medical, Inc. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2016
Date Received
January 27, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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