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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 K073434
Device Name BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
Applicant
BIPORE, INC.
31 INDUSTRIAL PKWY.
NORTHVALE,  NJ  07647
Applicant Contact KEITH PALUCH
Correspondent
BIPORE, INC.
31 INDUSTRIAL PKWY.
NORTHVALE,  NJ  07647
Correspondent Contact KEITH PALUCH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/06/2007
Decision Date 04/01/2008
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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