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FDA 510(k) Application Details - K964271
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K964271
Device Name
Unit, Operative Dental
Applicant
AIREL-WEST
2550 M STREET, N.W.
6TH FLOOR
WASHINGTON, DC 20037 US
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Contact
DANIEL A KRACOV
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
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More FDA Info for this Product Code
Date Received
10/25/1996
Decision Date
12/19/1997
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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