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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 K892070
Device Name GENERAL IVT NEEDLE GUIDE KIT, STERILE
Applicant
Amedic USA
Oxenstiernsgatan 31
115 27 Stockholm
Sweden,  SE
Applicant Contact ANDERS WEILANDT
Correspondent
Amedic USA
Oxenstiernsgatan 31
115 27 Stockholm
Sweden,  SE
Correspondent Contact ANDERS WEILANDT
Regulation Number884.2960
Classification Product Code
HGL  
Date Received03/31/1989
Decision Date 09/05/1989
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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