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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name guide, needle, surgical
510(k) Number K031173
Device Name NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
Applicant
NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO,  MA  02703
Applicant Contact RICK TRIPP
Correspondent
NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO,  MA  02703
Correspondent Contact RICK TRIPP
Regulation Number878.4800
Classification Product Code
GDF  
Date Received04/14/2003
Decision Date 07/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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