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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 K970756
Device Name MERCURY MEDICAL REUSABLE CPR BAG
Applicant
MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER,  FL  34622 -4800
Applicant Contact ARTHUR J WARD
Correspondent
MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER,  FL  34622 -4800
Correspondent Contact ARTHUR J WARD
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/03/1997
Decision Date 10/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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