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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K931175
Device Name SCHUSTER DISPOSABLE BALLOON PROBE
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 Number876.1620
Classification Product Code
FAP  
Date Received03/09/1993
Decision Date 04/01/1994
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
Recalls CDRH Recalls
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