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FDA 510(k) Application Details - K955932
Device Classification Name
Material, Impression
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510(K) Number
K955932
Device Name
Material, Impression
Applicant
GC AMERICA, INC.
3737 WEST 127TH ST.
ALSIP, IL 60803 US
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Contact
TERRY L JORTIZ
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Regulation Number
872.3660
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Classification Product Code
ELW
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More FDA Info for this Product Code
Date Received
12/13/1995
Decision Date
03/11/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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