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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Artery, Intraluminal
510(k) Number K020925
Device Name CARBODISSECTING ENDOSCOPE
Applicant
Endo Surgical Devices, Inc.
7 Tiffany Trail
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Endo Surgical Devices, Inc.
7 Tiffany Trail
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number870.4875
Classification Product Code
DWX  
Date Received03/21/2002
Decision Date 04/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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