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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, obstetric
510(k) Number K861578
Device Name ACUSON S328, L382, L538 & L312 TRANSDUCERS
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 Number884.2960
Classification Product Code
HGL  
Date Received04/28/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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