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510(k) K002632

OXYGENATOR by Adjunctive Therapeutics, Inc. — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2001
Date Received
August 23, 2000
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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  • K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (December 17, 2002)