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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K922356
Device Name FLOW CONTROL VALVE, CAT. NO. ACV-38
Applicant
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Applicant Contact KATHRYN BUCKLEIN
Correspondent
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Correspondent Contact KATHRYN BUCKLEIN
Regulation Number870.4400
Classification Product Code
MJJ  
Date Received05/19/1992
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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