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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 K761065
Device Name NEONATAL RESUSCITATOR, SAMSON
Applicant
DEM MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEM MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/18/1976
Decision Date 01/26/1977
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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