FDA 510(k) Application Details - K030802

Device Classification Name Saliva, Artificial

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510(K) Number K030802
Device Name Saliva, Artificial
Applicant INPHARMA A.S.
96 WEST MAIN ST.
NORTHBOROUGH, MA 01532 US
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Contact BRUCE MANNING
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 03/13/2003
Decision Date 11/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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