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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, Diagnostic
510(k) Number K972348
Device Name HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1087
Applicant Contact ROB BUTLER
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1087
Correspondent Contact ROB BUTLER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/24/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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