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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 K863312
Device Name SANDHILL AMS
Applicant
Sandhill
224 E. Olive Ave.
Burbank,  CA  91502
Applicant Contact ROBERT R CHAMBERS
Correspondent
Sandhill
224 E. Olive Ave.
Burbank,  CA  91502
Correspondent Contact ROBERT R CHAMBERS
Regulation Number876.1620
Classification Product Code
FAP  
Date Received08/26/1986
Decision Date 12/03/1986
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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