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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTHINPREP(R) PROCESSOR, MODEL TP 2000
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantHOLOGIC, INC.
PMA NumberP950039
Date Received11/22/1995
Decision Date05/20/1996
Product Code
MKQ[ Registered Establishments with MKQ ]
Docket Number 97M-0254
Notice Date 06/30/1997
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the thinprep 2000 system.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S020 S021 S024 S027 S028 
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