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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 K140603
Device Name ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
Applicant
Saphena Medical, Inc.
27392 Capricho
Mission Viejo,  CA  92692
Applicant Contact CHERYL BLAKE
Correspondent
Saphena Medical, Inc.
27392 Capricho
Mission Viejo,  CA  92692
Correspondent Contact CHERYL BLAKE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/10/2014
Decision Date 07/31/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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