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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 K895026
Device Name HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHARLES R BURR
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHARLES R BURR
Regulation Number884.2960
Classification Product Code
HGL  
Date Received08/08/1989
Decision Date 11/06/1989
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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