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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, Diagnostic
510(k) Number K062126
Device Name EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
Applicant
Biosphere Medical, Inc.
1050 Hingham St.
Rockland,  MA  02370
Applicant Contact IRINA KULINETS
Correspondent
Biosphere Medical, Inc.
1050 Hingham St.
Rockland,  MA  02370
Correspondent Contact IRINA KULINETS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/26/2006
Decision Date 08/09/2006
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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