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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 K961332
Device Name BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
Applicant
Medical Marketing Concepts
2310 York Rd.
Roanoke,  VA  24015
Applicant Contact BOB MARTIN
Correspondent
Medical Marketing Concepts
2310 York Rd.
Roanoke,  VA  24015
Correspondent Contact BOB MARTIN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/08/1996
Decision Date 06/28/1996
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
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