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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor, self-retaining
510(k) Number K860368
Device Name URDYN 5000 (UROFLOWMETER)
Applicant
DANTEC ELECTRONICS, INC.
6 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact HENRIK HENRIKSEN
Correspondent
DANTEC ELECTRONICS, INC.
6 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact HENRIK HENRIKSEN
Regulation Number876.4730
Classification Product Code
FFO  
Date Received02/03/1986
Decision Date 04/23/1986
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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