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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 K004040
Device Name REDTECH GIPC 2000
Applicant
Red-Tech, Inc.
27881 La Paz Rd.
Laguna Niguel,  CA 
Applicant Contact GARY MOCNIK
Correspondent
Red-Tech, Inc.
27881 La Paz Rd.
Laguna Niguel,  CA 
Correspondent Contact GARY MOCNIK
Regulation Number876.1725
Classification Product Code
FFX  
Date Received12/29/2000
Decision Date 03/29/2001
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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