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510(k) K210627

Breezeway II by Oscor, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2021
Date Received
March 2, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIES (August 29, 2012)

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