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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 K062852
Device Name BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
Applicant
ONSET MEDICAL CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
ONSET MEDICAL CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/25/2006
Decision Date 02/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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