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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 K923335
Device Name ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
Applicant
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact SOLOMITA, JR
Correspondent
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact SOLOMITA, JR
Regulation Number884.2960
Classification Product Code
HGL  
Date Received06/08/1992
Decision Date 07/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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