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510(k) K042483

INVACARE PRO, COMPACT AND PORTABLE DESKTOP by Invacare Corporation — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2005
Date Received
September 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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