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510(k) K201676

Device
Barricaid Instrument Tray
Applicant
Intrinsic Therapeutics, Inc.
510(k) number
K201676
Product code
QHG  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-16
Date received
2020-06-19
Regulation
888.4510
Classification name
Defect Measurement Tool
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Regina Shih
Address
30 Commerce Way Woburn MA US 01801 01801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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