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510(k) K180092

Intellitorq by Gauthier Biomedical, Inc. — Product Code HXC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 8, 2018
Date Received: January 12, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wrench
Device Class: Class I
Regulation Number: 888.4540
Review Panel: OR
Submission Type