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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, Powered (Resuscitator)
510(k) Number K771299
Device Name EMERGENCY OXYGEN RESUSCITATOR
Applicant
FRASER SWEATMAN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FRASER SWEATMAN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5925
Classification Product Code
BTL  
Date Received07/14/1977
Decision Date 08/04/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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