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FDA 510(k) Application Details - K053328
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K053328
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
SATELEC
130 GAITHER DRIVE
SUITE 100
MT. LAUREL, NJ 08054 US
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Contact
STEVEN SALESKY
Other 510(k) Applications for this Contact
Regulation Number
872.3760
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Classification Product Code
EBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2005
Decision Date
01/25/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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