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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K934753
Device Name STAR BREATHING CIRCUITS
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 Number868.5975
Classification Product Code
BZO  
Date Received10/04/1993
Decision Date 10/27/1993
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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