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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 K885061
Device Name SIEMENS INTRAVAGINAL TRANSDUCER
Applicant
Siemens Medical Solutions USA, Inc.
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Applicant Contact K JOHNSON
Correspondent
Siemens Medical Solutions USA, Inc.
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Correspondent Contact K JOHNSON
Regulation Number884.2225
Classification Product Code
HEM  
Date Received12/06/1988
Decision Date 02/23/1989
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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