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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 K953546
Device Name MANUAL PULMONARY RESUSICITATOR
Applicant
MEDICAL MARKETING CONCEPTS
20 BREEDEN COURT
HARDY,  VA  24101
Applicant Contact BOB MARTIN
Correspondent
MEDICAL MARKETING CONCEPTS
20 BREEDEN COURT
HARDY,  VA  24101
Correspondent Contact BOB MARTIN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received07/28/1995
Decision Date 02/29/1996
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
Recalls CDRH Recalls
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