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510(k) K963848

MANUAL RESUSCITATOR by Owens-Brigam Medical Co. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1997
Date Received
September 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

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