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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord, electric, for endoscope
510(k) Number K111013
Device Name ACEM
Applicant
SANDHILL SCIENTIFIC, INC.
4655 KIRKWOOD CT
BOULDER,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
SANDHILL SCIENTIFIC, INC.
4655 KIRKWOOD CT
BOULDER,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number876.1500
Classification Product Code
FFZ  
Subsequent Product Codes
JOM   MYE  
Date Received04/11/2011
Decision Date 12/19/2011
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
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