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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 K955679
Device Name RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
Applicant
CONTOUR FABRICATORS OF FLORIDA, INC.
1247 FLORIDA AVE.
PALM HARBOR,  FL  34683
Applicant Contact PATRICK J LAMB
Correspondent
CONTOUR FABRICATORS OF FLORIDA, INC.
1247 FLORIDA AVE.
PALM HARBOR,  FL  34683
Correspondent Contact PATRICK J LAMB
Regulation Number884.1550
Classification Product Code
HIO  
Subsequent Product Code
HGL  
Date Received12/14/1995
Decision Date 03/12/1996
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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