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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K100966
Device Name COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
Applicant
Sheathing Technologies, Inc.
18431 Technology Dr.
Morgan Hill,  CA  95037
Applicant Contact JENNIFER DOWNING
Correspondent
Sheathing Technologies, Inc.
18431 Technology Dr.
Morgan Hill,  CA  95037
Correspondent Contact JENNIFER DOWNING
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
ODB  
Date Received04/08/2010
Decision Date 08/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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