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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K862365
Device Name NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
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 Number884.1550
Classification Product Code
HIO  
Date Received06/24/1986
Decision Date 07/07/1986
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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