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FDA 510(k) Application Details - K002632
Device Classification Name
Chamber, Oxygen, Topical, Extremity
More FDA Info for this Device
510(K) Number
K002632
Device Name
Chamber, Oxygen, Topical, Extremity
Applicant
ADJUNCTIVE THERAPEUTICS, INC.
10 SCOTCH MIST COURT
POTOMAC, MD 20854 US
Other 510(k) Applications for this Company
Contact
MYRON Z BERNSTEIN
Other 510(k) Applications for this Contact
Regulation Number
878.5650
More FDA Info for this Regulation Number
Classification Product Code
KPJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/23/2000
Decision Date
10/25/2001
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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