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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 K953617
Device Name RESPOSABLE RESUSCITATOR
Applicant
Medical Marketing Concepts
20 Breeden Ct.
Hardy,  VA  24101
Applicant Contact BOB MARTIN
Correspondent
Medical Marketing Concepts
20 Breeden Ct.
Hardy,  VA  24101
Correspondent Contact BOB MARTIN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/03/1995
Decision Date 11/22/1995
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
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