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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K853711
Device Name 5.0 MHZ INTRACAVITARY SECTOR PROBE
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact JAMES M HOWARD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact JAMES M HOWARD
Regulation Number884.2225
Classification Product Code
HEM  
Date Received09/05/1985
Decision Date 12/18/1985
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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