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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defect Measurement Tool
510(k) Number K201676
Device Name Barricaid Instrument Tray
Applicant
Intrinsic Therapeutics, Inc.
30 Commerce Way
Woburn,  MA  01801
Applicant Contact Regina Shih
Correspondent
Intrinsic Therapeutics, Inc.
30 Commerce Way
Woburn,  MA  01801
Correspondent Contact Regina Shih
Classification Product Code
QHG  
Date Received06/19/2020
Decision Date 07/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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