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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 K852289
Device Name MODEL SA3 ESOPHAGEAL PH ELECTRODE
Applicant
WORLD PRECISION INSTRUMENTS, INC.
375 QUINNIPIAC AVE.
NEW HAVEN,  CT  06513
Applicant Contact JANET B FEIN
Correspondent
WORLD PRECISION INSTRUMENTS, INC.
375 QUINNIPIAC AVE.
NEW HAVEN,  CT  06513
Correspondent Contact JANET B FEIN
Regulation Number876.1400
Classification Product Code
FFT  
Date Received05/29/1985
Decision Date 07/25/1985
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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