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FDA 510(k) Application Details - K960756
Device Classification Name
Chamber, Oxygen, Topical, Extremity
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510(K) Number
K960756
Device Name
Chamber, Oxygen, Topical, Extremity
Applicant
LIFETECH SYSTEMS, INC.
11350 RANDOM HILLS RD. #800
FAIRFAX, VA 22030 US
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Contact
JOHN OBERST
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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
02/23/1996
Decision Date
08/29/1997
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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