FDA 510(k) Application Details - K052708

Device Classification Name Campylobacter Pylori

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510(K) Number K052708
Device Name Campylobacter Pylori
Applicant ARJ MEDICAL, INC.
209 STATE STREET
OLDSMAR, FL 34677 US
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Contact PHILIP ROSS
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Regulation Number 866.3110

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Classification Product Code LYR
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Date Received 09/29/2005
Decision Date 05/01/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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