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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 K921553
Device Name LSPI INFANT BAG MASK
Applicant
Life Support Products, Inc.
One Mauchly
Irvine,  CA  92718
Applicant Contact VERNON TRIMBLE
Correspondent
Life Support Products, Inc.
One Mauchly
Irvine,  CA  92718
Correspondent Contact VERNON TRIMBLE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/01/1992
Decision Date 10/19/1992
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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