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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K062050
Device Name FLEXVIEW SYSTEM
Applicant
Boston Scientific
3200 Lakeside Dr.
Santa Clara,  CA  95033
Applicant Contact CHRISTINA L ROWE
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/20/2006
Decision Date 07/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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