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510(k) K023683

MULTI-STRAP FULL FACE MASK by Engineered Medical Systems — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2003
Date Received
November 1, 2002
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

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