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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Cystometric, Hydraulic
510(k) Number K960503
Device Name DANTEC DUET
Applicant
Dantec Medical, Inc.
3 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact ALAN J SCHAEFER
Correspondent
Dantec Medical, Inc.
3 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact ALAN J SCHAEFER
Regulation Number876.1620
Classification Product Code
FEN  
Subsequent Product Code
FAP  
Date Received02/02/1996
Decision Date 09/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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