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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 -1402
Applicant Contact JIM HITCHIN
Correspondent
INFRASONICS CORP.
3911 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121 -1402
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
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