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FDA 510(k) Application Details - K023456
Device Classification Name
Chamber, Oxygen, Topical, Extremity
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510(K) Number
K023456
Device Name
Chamber, Oxygen, Topical, Extremity
Applicant
OXYFAST CORPORATION
11000 CEDAR AVE # 449
CLEVELAND, OH 44106 US
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Contact
MELVYN BURKE
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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
10/15/2002
Decision Date
02/24/2003
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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