FDA 510(k) Application Details - K981949

Device Classification Name Chamber, Oxygen, Topical, Extremity

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510(K) Number K981949
Device Name Chamber, Oxygen, Topical, Extremity
Applicant NUMOTECH, INC.
21800 OXNARD ST., SUITE 840
WARNER CENTER PLAZA
WOODLAND HILLS, CA 91367 US
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Contact W. PATRICK NOONAN
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Regulation Number 878.5650

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Classification Product Code KPJ
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Date Received 06/03/1998
Decision Date 02/03/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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