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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K212988
Device Name ONO Retrieval Device
Applicant
Onocor Vascular, LLC
808 General Sterling Dr.
West Chester,  PA  19382
Applicant Contact Tiffini Wittwer
Correspondent
Onocor Vascular, LLC
808 General Sterling Dr.
West Chester,  PA  19382
Correspondent Contact Tiffini Wittwer
Regulation Number870.5150
Classification Product Code
MMX  
Date Received09/20/2021
Decision Date 05/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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