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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K152931
Device Name Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
Applicant
AMBU A/S
BALTORPBAKKEN 13
BALLERUP,  DK DK-2750
Applicant Contact LINE KAGENOW SVENSTRUP
Correspondent
AMBU INC.
6230 OLD DOBBIN LANE, SUITE 250
COLUMBIA,  MD  21045
Correspondent Contact SANJAY PARIKH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/05/2015
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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