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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDILAPAN(TM)
Classification Namedilator, cervical, synthetic osmotic
Generic Namesynthetic osmotic cervical dilator
ApplicantGYNOTECH, INC.
PMA NumberP840045
Supplement NumberS002
Date Received08/04/1987
Decision Date09/28/1988
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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