FDA 510(k) Application Details - K001493

Device Classification Name Unit, Oral Irrigation

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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
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Regulation Number 872.6510

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Classification Product Code EFS
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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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