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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 K070247
Device Name GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
Applicant
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Applicant Contact AGATA SMIEJA
Correspondent
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Correspondent Contact AGATA SMIEJA
Regulation Number868.5915
Classification Product Code
BTM  
Date Received01/25/2007
Decision Date 04/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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