FDA 510(k) Application Details - K041563

Device Classification Name Saliva, Artificial

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510(K) Number K041563
Device Name Saliva, Artificial
Applicant GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
1500 LITTLETON RD.
PARSIPPANY, NJ 07054 US
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Contact ANTHONY G AMITRANO
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 06/10/2004
Decision Date 08/27/2004
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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