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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 K864219
Device Name TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
Applicant
AMEDIC USA
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Applicant Contact JACK MOORE
Correspondent
AMEDIC USA
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Correspondent Contact JACK MOORE
Regulation Number884.2960
Classification Product Code
HGL  
Date Received10/28/1986
Decision Date 03/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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