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510(k) K033028

ANEFIN, MODEL 100 by Axon Medical — Product Code CBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2005
Date Received
September 26, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

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