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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 K863298
Device Name DIAMOND MEDICAL, INC., MODEL DM 700
Applicant
DIAMOND MEDICAL, INC.
355 SHERMAN ST.
SUITE #405
SAINT PAUL,  MN  55102
Applicant Contact RENELLE L NEAL
Correspondent
DIAMOND MEDICAL, INC.
355 SHERMAN ST.
SUITE #405
SAINT PAUL,  MN  55102
Correspondent Contact RENELLE L NEAL
Regulation Number876.1400
Classification Product Code
FFT  
Date Received08/25/1986
Decision Date 03/17/1987
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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