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510(k) K161483

Unger Quad Injector by Stradis Healthcare — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2016
Date Received
May 31, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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