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510(k) K922356

Device
FLOW CONTROL VALVE, CAT. NO. ACV-38
Applicant
AMERICAN OMNI MEDICAL, INC.
510(k) number
K922356
Product code
MJJ  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-12
Date received
1992-05-19
Regulation
870.4400
Classification name
Cpb Check Valve, Retrograde Flow, In-line
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHRYN BUCKLEIN
Address
2930-G Grace Ln. Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MJJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182442MiniGuard Arterial Safety ValveQuest Medical, Inc.2018-11-06
K142500One Way Soft ValveTerumo Cardiovascular Systems Corporation2015-01-29
K0012453T L. V. CONTROL VALVE3t Medical Systems, LLC2001-08-15
K992785IBC FLOGUARD, MODEL 6050International Biophysics Corp.2000-01-14
K982406COBE VACUUM RELIEF CHECK VALVECobe Cardiovascular, Inc.1998-10-07
K960937SUCTION SAFETY DEVICER D Intl.1996-06-05
K922781FLOW CONROL VALVEAmerican Omni Medical, Inc.1993-03-08
K921500CENTRI-SAFE(TM) VALVECardio Systems, Inc.1992-09-15

Legacy Summary#

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FDA Review#

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