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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 K963848
Device Name MANUAL RESUSCITATOR
Applicant
Owens-Brigam Medical Co.
65 Hanes Rd.
Newland,  NC  28657
Applicant Contact BILL BROOKS
Correspondent
Owens-Brigam Medical Co.
65 Hanes Rd.
Newland,  NC  28657
Correspondent Contact BILL BROOKS
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/25/1996
Decision Date 07/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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