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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, Long-Term Greater Than 30 Days
510(k) Number K070002
Device Name BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
Applicant
BOSTONSCIENTIFIC
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact NICHOLAS CONDAKES
Correspondent
BOSTONSCIENTIFIC
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact NICHOLAS CONDAKES
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/03/2007
Decision Date 08/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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