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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K963064
Device Name ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
Applicant
LABORIE MEDICAL TECH CORP.
6 HURRICANE LANE, #2
WILLISTON,  VT  05495
Applicant Contact THOMAS HIRTE
Correspondent
LABORIE MEDICAL TECH CORP.
6 HURRICANE LANE, #2
WILLISTON,  VT  05495
Correspondent Contact THOMAS HIRTE
Regulation Number876.1725
Classification Product Code
FFX  
Date Received08/07/1996
Decision Date 06/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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