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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K861051
Device Name ISOLIFE DISPENSING SYSTEM
Applicant
NAVACO LABORATORIES
412 ASH AVE.
MCALLEN,  TX  78501
Applicant Contact SCHROCK, SR.
Correspondent
NAVACO LABORATORIES
412 ASH AVE.
MCALLEN,  TX  78501
Correspondent Contact SCHROCK, SR.
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/19/1986
Decision Date 04/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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