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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 K952878
Device Name OXY/STAR LOW FLOW BLENDER
Applicant
Infrasonics Corp.
3911 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact JIM HITCHIN
Correspondent
Infrasonics Corp.
3911 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact JIM HITCHIN
Regulation Number868.5330
Classification Product Code
BZR  
Date Received06/23/1995
Decision Date 09/25/1995
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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