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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 K780216
Device Name LIFESAVER, MANUAL #5160
Applicant
HUDSON OXYGEN THERAPY SALES CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HUDSON OXYGEN THERAPY SALES CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5915
Classification Product Code
BTM  
Date Received02/10/1978
Decision Date 03/14/1978
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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