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510(k) K083751

INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 by Invacare Corporation — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2009
Date Received
December 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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