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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K904231
Device Name MODEL OSP, SANDHILL AMS
Applicant
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120 -4535
Applicant Contact JUDY GRIFFITH
Correspondent
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120 -4535
Correspondent Contact JUDY GRIFFITH
Regulation Number876.4620
Classification Product Code
FAD  
Date Received08/28/1990
Decision Date 01/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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