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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 K911622
Device Name CPR BAG
Applicant
MERCED MEDICAL, INC.
113300 A-49TH ST. NORTH
CLEARWATER,  FL  34622
Applicant Contact JEFF RATNER
Correspondent
MERCED MEDICAL, INC.
113300 A-49TH ST. NORTH
CLEARWATER,  FL  34622
Correspondent Contact JEFF RATNER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/11/1991
Decision Date 05/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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