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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K183374
Device Name GrayDuck Stent
Applicant
Poll Medical, LLC
8630 SW Scholls Ferry Rd., Suite 225
Beaverton,  OR  97008
Applicant Contact Adrian Polliack
Correspondent
Allegiance Regulatory Consulting, LLC
16642 SW Lansford Ct.
Beaverton,  OR  97007
Correspondent Contact Alyssa Thomas
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/06/2018
Decision Date 02/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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