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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 K964814
Device Name BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
Applicant
BIPORE, INC.
31 INDUSTRIAL PKWY.
NORTHVALE,  NJ  07647
Applicant Contact DURMUS KOCH
Correspondent
BIPORE, INC.
31 INDUSTRIAL PKWY.
NORTHVALE,  NJ  07647
Correspondent Contact DURMUS KOCH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/29/1996
Decision Date 05/07/1997
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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