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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K896713
Device Name ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
Applicant
Advanced Surgical Intervention, Inc.
951 Calle Amanecer
San Clemente,  CA  92672
Applicant Contact BARRY M CALVARESE
Correspondent
Advanced Surgical Intervention, Inc.
951 Calle Amanecer
San Clemente,  CA  92672
Correspondent Contact BARRY M CALVARESE
Regulation Number876.5520
Classification Product Code
KOE  
Date Received11/29/1989
Decision Date 05/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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