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510(k) K121747

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS by Intersurgical Incorporated — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2013
Date Received
June 14, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Intersurgical Incorporated

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