FDA 510(k) Application Details - K100066

Device Classification Name Medical Computers And Software

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510(K) Number K100066
Device Name Medical Computers And Software
Applicant WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
BALTIMORE, MD 21202 US
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Contact MALINDA PEEPLES
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Regulation Number 000.0000

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Classification Product Code LNX
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Date Received 01/11/2010
Decision Date 07/15/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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