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510(k) K982891

Device
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
510(k) number
K982891
Product code
DTS  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-30
Date received
1998-08-17
Regulation
870.4420
Classification name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MEHMET BICAKCI
Address
2681 Kelvin Ave. Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053021ESTECH CLEARVIEW MV ATRIAL DEPRESSOREstech, Inc.2006-01-26
K963756IBC CARDIAC SUCTION WARDInternational Biophysics Corp.1997-11-14
K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.1991-01-23
K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.1990-03-28
K891906ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.1989-06-13
K801641OHIO DISPOSABLE CLEAR SUCTION INSTRUMENTOhio Medical Products1980-07-28
K801400DISPOSABLE SUCKER SYSTEMTexas Medical Products, Inc.1980-06-30
K791846DISPOSSABLE SUCTION TUBE, 6 FRENCHDlp, Inc.1979-10-02

Legacy Summary#

summary

FDA Review#

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