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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, ph, stomach
510(k) Number K910694
Device Name ZINETICS INTERNAL REFERENCE PROBE
Applicant
ZINETICS MEDICAL, INC.
2212 SOUTH WEST TEMPLE, #48
SALT LAKE CITY,  UT  84115
Applicant Contact RUSS GARRISON
Correspondent
ZINETICS MEDICAL, INC.
2212 SOUTH WEST TEMPLE, #48
SALT LAKE CITY,  UT  84115
Correspondent Contact RUSS GARRISON
Regulation Number876.1400
Classification Product Code
FFT  
Date Received02/19/1991
Decision Date 05/17/1991
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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