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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 W. Campus Dr.
Littleton,  CO  80120
Applicant Contact JACQUELINE Q THOMAS
Correspondent
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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