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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K023288
Device Name COBRA BIPOLAR CLAMP, MODEL 15902
Applicant
BOSTON SCIENTIFIC EP TECHNOLOGIES
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact APRIL MALMBORG
Correspondent
BOSTON SCIENTIFIC EP TECHNOLOGIES
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact APRIL MALMBORG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/02/2002
Decision Date 04/02/2003
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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