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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 K896031
Device Name AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
Applicant
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number884.1550
Classification Product Code
HIO  
Date Received10/16/1989
Decision Date 01/12/1990
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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