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510(k) K094003

REVIVATOR by Hersill, S.L. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2010
Date Received
December 28, 2009
Clearance Type
Abbreviated
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

Other clearances by Hersill, S.L.

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