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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 NameLAMICEL OSMOTIC CERVICAL DILATOR
Classification Namedilator, cervical, synthetic osmotic
Generic Namecervical dilator
ApplicantMEROCEL SCIENTIFIC PRODUCTS
PMA NumberP820075
Supplement NumberS009
Date Received06/24/1999
Decision Date07/16/1999
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
Approval Order Statement 
Approval for a new sterilization facility located at sterigenics intl. , inc. , 10811 withers cove park dr. , charlotte, n. C.
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