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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 K931963
Device Name SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
Applicant
SANDHILL SCIENTIFIC, INC.
1501-N WEST CAMPUS DR.
LITTLETON,  CO  80120 -4535
Applicant Contact JACQUELINE Q THOMAS
Correspondent
SANDHILL SCIENTIFIC, INC.
1501-N WEST CAMPUS DR.
LITTLETON,  CO  80120 -4535
Correspondent Contact JACQUELINE Q THOMAS
Regulation Number876.1400
Classification Product Code
FFT  
Date Received04/21/1993
Decision Date 09/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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