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510(k) K022028

VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER by Vascular One, Inc. — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2002
Date Received
June 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type

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  • K020466 — HEC 1000 (May 8, 2002)