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510(k) K161004

Self-retaining Retractor by Fetzer Medical GmbH & Co. KG — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2016
Date Received
April 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

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