Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GK-101E CARIES REMOVAL AGENT/SYSTEM |
Generic Name | SOLUTION, REMOVAL, CARRIES |
Applicant | INDEVUS PHARMACEUTICALS, INC. 8 CLARKE DR. CRANBURY, NJ 08512 |
PMA Number | P830035 |
Supplement Number | S001 |
Date Received | 10/01/1984 |
Decision Date | 04/18/1985 |
Withdrawal Date
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10/22/2007 |
Product Code |
LMW |
Advisory Committee |
Dental |
Expedited Review Granted? | No |
Combination Product | No |
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