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510(k) K060094

ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES by Arcadia Medical Corporation — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2006
Date Received
January 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Arcadia Medical Corporation

  • K031553 — SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC (November 18, 2003)

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