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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 K761230
Device Name AMMOCENTESIS TRAY (KIT)
Applicant
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1550
Classification Product Code
HIO  
Date Received12/10/1976
Decision Date 12/17/1976
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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