FDA 510(k) Application Details - K974655

Device Classification Name Airbrush

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510(K) Number K974655
Device Name Airbrush
Applicant PREP TECHNOLOGY CORP.
43204 CHRISTY ST.
FREEMONT, CA 94538 US
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Contact JOE W SHAFFER
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Regulation Number 872.6080

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Classification Product Code KOJ
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Date Received 12/15/1997
Decision Date 07/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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