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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 K982215
Device Name MANUAL RESUSCITATOR WITH ACE
Applicant
MEDICAL MARKETING CONCEPTS
P.O. BOX 4341
CROFTON,  MD  21114 -4341
Applicant Contact E J SMITH
Correspondent
MEDICAL MARKETING CONCEPTS
P.O. BOX 4341
CROFTON,  MD  21114 -4341
Correspondent Contact E J SMITH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/23/1998
Decision Date 09/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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