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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 K860180
Device Name MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
Applicant
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Applicant Contact DONALD C FABISH
Correspondent
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Correspondent Contact DONALD C FABISH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received01/21/1986
Decision Date 03/06/1986
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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