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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 K940079
Device Name ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
Original Applicant
ARROW INTL., INC.
3000 bernville rd.
reading,  PA  19605
Original Contact thomas d nickel
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/07/1994
Decision Date 11/30/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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