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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intrauterine
510(k) Number K885316
Device Name DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Applicant Contact VAN DEUSEN
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Correspondent Contact VAN DEUSEN
Regulation Number884.2700
Classification Product Code
KXO  
Date Received12/29/1988
Decision Date 03/23/1989
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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