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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 NameDEXTRAN HM 32%
Classification Namefluid, hysteroscopy
Generic Namehysteroscopy fluid
ApplicantHOSPIRA, INC.
PMA NumberP880028
Date Received04/12/1988
Decision Date05/30/1989
Withdrawal Date 12/19/2007
Product Code
Docket Number 89M-0194
Notice Date 06/29/1989
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S006 S007 S008