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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K040786
Device Name VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
Applicant
Neometrics, Inc.
14800 28th Ave. N.
Suite 150
Plymouth,  MN  55447
Applicant Contact GENE CHAMPEAU
Correspondent
Neometrics, Inc.
14800 28th Ave. N.
Suite 150
Plymouth,  MN  55447
Correspondent Contact GENE CHAMPEAU
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/29/2004
Decision Date 04/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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