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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 K915810
Device Name MER BAG
Applicant
Merced Medical, Inc.
113300 A-49th St. N.
Clearwater,  FL  34622
Applicant Contact JEFF RATNER
Correspondent
Merced Medical, Inc.
113300 A-49th St. N.
Clearwater,  FL  34622
Correspondent Contact JEFF RATNER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/24/1991
Decision Date 03/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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