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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K974015
Device Name ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
Applicant
Davis & Geck, Inc.
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Applicant Contact STEPHEN J TAMSETT
Correspondent
Davis & Geck, Inc.
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Correspondent Contact STEPHEN J TAMSETT
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/22/1997
Decision Date 05/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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