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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K210627
Device Name Breezeway II
Applicant
Oscor Inc.
3816 DeSoto Boulevard
Palm Harbor,  FL  34683
Applicant Contact Doug Myers
Correspondent
Oscor Inc.
3816 DeSoto Boulevard
Palm Harbor,  FL  34683
Correspondent Contact Doug Myers
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/02/2021
Decision Date 06/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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