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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Calibration, Gas
510(k) Number K860516
Device Name LSP MINILATOR
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 Number868.2350
Classification Product Code
BXY  
Date Received02/11/1986
Decision Date 02/21/1986
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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