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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 K952031
Device Name ULTRASOUND TRANSDUCER, MODEL US917
Applicant
ADVANCED MEDICAL SYSTEMS, INC.
925 SHERMAN AVE.
HAMDEN,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
ADVANCED MEDICAL SYSTEMS, INC.
925 SHERMAN AVE.
HAMDEN,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number884.2960
Classification Product Code
HGL  
Date Received05/01/1995
Decision Date 07/18/1995
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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