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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGK-101E CARIES REMOVAL AGENT/SYSTEM
Classification Namesolution, removal, carries
Generic Namesolution, removal, carries
Applicant
INDEVUS PHARMACEUTICALS, INC.
8 clarke dr.
cranbury, NJ 08512
PMA NumberP830035
Date Received07/01/1983
Decision Date07/06/1984
Withdrawal Date 10/22/2007
Product Code
LMW
Docket Number 84M-0248
Notice Date 05/02/1986
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 
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