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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, Obstetric
510(k) Number K860621
Device Name 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
Applicant
Impex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact KIRK OLSEN
Correspondent
Impex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact KIRK OLSEN
Regulation Number884.2960
Classification Product Code
HGL  
Date Received02/19/1986
Decision Date 05/20/1986
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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