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FDA 510(k) Application Details - K112634
Device Classification Name
Chamber, Oxygen, Topical, Extremity
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510(K) Number
K112634
Device Name
Chamber, Oxygen, Topical, Extremity
Applicant
INOTEC AMD LTD.
2995 STEVEN MARTIN DR.
FAIRFAX, VA 22031 US
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Contact
Diane Horwitz
Other 510(k) Applications for this Contact
Regulation Number
878.5650
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Classification Product Code
KPJ
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More FDA Info for this Product Code
Date Received
09/09/2011
Decision Date
07/03/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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