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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K861579
Device Name ACUSON L558 TRANSDUCER
Applicant
Acuson Computed Sonography
1220 Charleston Rd.
P.O. Box 7393
Mountain View,  CA  94039
Applicant Contact ROBERT J GALLAGHER
Correspondent
Acuson Computed Sonography
1220 Charleston Rd.
P.O. Box 7393
Mountain View,  CA  94039
Correspondent Contact ROBERT J GALLAGHER
Regulation Number870.2880
Classification Product Code
JOP  
Date Received04/28/1986
Decision Date 07/30/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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