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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 K901336
Device Name ASI HEMOSTASIS CATHETER
Applicant
ADVANCED SURGICAL INTERVENTION, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92672
Applicant Contact M CALVARESE,MS
Correspondent
ADVANCED SURGICAL INTERVENTION, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92672
Correspondent Contact M CALVARESE,MS
Regulation Number876.5130
Classification Product Code
GBM  
Date Received03/22/1990
Decision Date 06/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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