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510(k) K932799

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE by Engineered Medical Systems — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1993
Date Received
June 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

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