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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name angioscope
510(k) Number K931421
Device Name DISPOSABLE STEERABLE ANGIOSCOPE
Applicant
ENDOVASCULAR, INC.
3180 PULLMAN ST.
COSTA MESA,  CA  92626
Applicant Contact KAREN U SALINAS
Correspondent
ENDOVASCULAR, INC.
3180 PULLMAN ST.
COSTA MESA,  CA  92626
Correspondent Contact KAREN U SALINAS
Regulation Number876.1500
Classification Product Code
LYK  
Date Received03/22/1993
Decision Date 06/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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