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FDA 510(k) Application Details - K001493
Device Classification Name
Unit, Oral Irrigation
More FDA Info for this Device
510(K) Number
K001493
Device Name
Unit, Oral Irrigation
Applicant
AIR FORCE, INC.
933 BUTTERNUT DR.
HOLLAND, MI 49424 US
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Contact
PIERO POLICICCHIO
Other 510(k) Applications for this Contact
Regulation Number
872.6510
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Classification Product Code
EFS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/12/2000
Decision Date
10/25/2000
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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