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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 K954866
Device Name MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
Applicant
Mercury Medical
11300 49th St. N.
Clearwater,  FL  33762 -4800
Applicant Contact KATHY L HANN
Correspondent
Mercury Medical
11300 49th St. N.
Clearwater,  FL  33762 -4800
Correspondent Contact KATHY L HANN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/24/1995
Decision Date 01/30/1996
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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