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510(k) K032596

STURDY MANUAL RESUSCITATOR by Sturdy Industrial Co., Ltd. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2004
Date Received
August 22, 2003
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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