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FDA 510(k) Application Details - K963777
Device Classification Name
Chamber, Oxygen, Topical, Extremity
More FDA Info for this Device
510(K) Number
K963777
Device Name
Chamber, Oxygen, Topical, Extremity
Applicant
STEPHENSON INDUSTRIES, INC.
1648 BEAVER DAM RD.
POINT PLEASANT, NJ 08742 US
Other 510(k) Applications for this Company
Contact
R A LASHLY
Other 510(k) Applications for this Contact
Regulation Number
878.5650
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Classification Product Code
KPJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/1996
Decision Date
07/28/1997
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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