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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K952924
Device Name ADI CATHETER WITH VALVE
Applicant
ASIA DYNAMICS, INC.
5745 WEST HOWARD ST.
NILES,  IL  60714
Applicant Contact CHRISTI GERARD
Correspondent
ASIA DYNAMICS, INC.
5745 WEST HOWARD ST.
NILES,  IL  60714
Correspondent Contact CHRISTI GERARD
Regulation Number876.5130
Classification Product Code
GBM  
Date Received06/26/1995
Decision Date 08/18/1995
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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