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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 K864308
Device Name BAUMAN CPR/RESPIRATOR
Applicant
General Medical Products, Inc.
1831 Centinela Ave.
Santa Monica,  CA  90404
Applicant Contact BAUMAN, M.D.
Correspondent
General Medical Products, Inc.
1831 Centinela Ave.
Santa Monica,  CA  90404
Correspondent Contact BAUMAN, M.D.
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/03/1986
Decision Date 03/09/1987
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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