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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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