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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Mask, Oxygen
510(k) Number K874092
Device Name MASK, OXYGEN
Applicant
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Applicant Contact TOM FANGROW
Correspondent
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Correspondent Contact TOM FANGROW
Regulation Number868.5580
Classification Product Code
BYG  
Date Received10/08/1987
Decision Date 02/11/1988
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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