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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 K851171
Device Name COMBIBAG MANUAL RESUSCITATOR
Applicant
FRONTLINE MEDICAL CORP.
8501 65TH ST. NORTH
PINELLAS PARK,  FL  34665
Applicant Contact FOSTER
Correspondent
FRONTLINE MEDICAL CORP.
8501 65TH ST. NORTH
PINELLAS PARK,  FL  34665
Correspondent Contact FOSTER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/22/1985
Decision Date 09/06/1985
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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