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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 K852132
Device Name MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Applicant Contact JAMES F KISTLER
Correspondent
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Correspondent Contact JAMES F KISTLER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/16/1985
Decision Date 08/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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