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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Uroflowmeter
510(k) Number K894968
Device Name ULTRACOMPACT
Applicant
EUTECTIC ELECTRONICS, INC.
8608 JERSEY COURT
RALEIGH,  NC  27612
Applicant Contact LARRY DANIEL
Correspondent
EUTECTIC ELECTRONICS, INC.
8608 JERSEY COURT
RALEIGH,  NC  27612
Correspondent Contact LARRY DANIEL
Regulation Number876.1800
Classification Product Code
EXY  
Date Received08/07/1989
Decision Date 11/08/1989
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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