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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 K884920
Device Name RECTUM-COLON MOTILITY MONITOR
Applicant
MULTI-SPECTRUM CONSULTING, INC.
4649 SYCAMORE ST.
HOLT,  MI  48842
Applicant Contact DOUGLAS J ROBSON
Correspondent
MULTI-SPECTRUM CONSULTING, INC.
4649 SYCAMORE ST.
HOLT,  MI  48842
Correspondent Contact DOUGLAS J ROBSON
Regulation Number876.1620
Classification Product Code
FAP  
Date Received11/28/1988
Decision Date 12/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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