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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 K081004
Device Name PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
Applicant
Stryker GI
1420 Lakeside Pkwy., #110
Flower Mound,  TX  75028
Applicant Contact TIFFANI ROGERS
Correspondent
Stryker GI
1420 Lakeside Pkwy., #110
Flower Mound,  TX  75028
Correspondent Contact TIFFANI ROGERS
Regulation Number876.1500
Classification Product Code
FDF  
Date Received04/08/2008
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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