FDA 510(k) Application Details - K970249

Device Classification Name Airbrush

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510(K) Number K970249
Device Name Airbrush
Applicant SIMPLEX MEDICAL SYSTEMS, INC.
430 ANSIN BLVD.
SUITE G
HALLANDALE, FL 33009 US
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Contact JOHN E TRAFTON
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Regulation Number 872.6080

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Classification Product Code KOJ
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Date Received 01/22/1997
Decision Date 05/07/1997
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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