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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K941010
Device Name ACUCISE GUIDEWIRE EXCHANGE SHEATH
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact RICHARD A BASLER
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact RICHARD A BASLER
Regulation Number876.5130
Classification Product Code
EYB  
Date Received03/03/1994
Decision Date 04/18/1994
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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