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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K992503
Device Name SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
Applicant
Sechrist Industries, Inc.
4225 E. La Palma
Anaheim,  CA  92807
Applicant Contact GREG GODFREY
Correspondent
Sechrist Industries, Inc.
4225 E. La Palma
Anaheim,  CA  92807
Correspondent Contact GREG GODFREY
Regulation Number868.5330
Classification Product Code
BZR  
Date Received07/27/1999
Decision Date 08/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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