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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 K082056
Device Name ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
Applicant
Life-Tech, Inc.
4235 Greenbriar Dr.
Stafford,  TX  77477
Applicant Contact JEFF KASOFF
Correspondent
Life-Tech, Inc.
4235 Greenbriar Dr.
Stafford,  TX  77477
Correspondent Contact JEFF KASOFF
Regulation Number876.1725
Classification Product Code
FFX  
Date Received07/21/2008
Decision Date 11/07/2008
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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