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FDA 510(k) Application Details - K964177
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K964177
Device Name
Material, Impression
Applicant
NORTH AMERICAN ORTHODONTIC LABORATORIES, INC.
200 E. PECAN ST.
GAINSVILLE, TX 76240 US
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Contact
MARGARET H CHRISTOPHERSON
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
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More FDA Info for this Product Code
Date Received
10/18/1996
Decision Date
12/30/1996
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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