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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 K862364
Device Name NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
Applicant
Swemed Laboratories, Inc.
Fullriggaregatan 12 B
S-421 74 V.Frolunda
Sweden,  SE
Applicant Contact GORAN ITSKOWITZ
Correspondent
Swemed Laboratories, Inc.
Fullriggaregatan 12 B
S-421 74 V.Frolunda
Sweden,  SE
Correspondent Contact GORAN ITSKOWITZ
Regulation Number884.2225
Classification Product Code
HEM  
Date Received06/24/1986
Decision Date 08/19/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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