CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CALIFORNIA MEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for California Medical Laboratories Inc. Malleable Vent Catheter.

Pre-market Notification Details

Device IDK981601
510k NumberK981601
Device Name:CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine,  CA  92614
ContactMehmet Bicakci
CorrespondentMehmet Bicakci
CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine,  CA  92614
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-04
Decision Date1998-07-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10803622106498 K981601 000
10803622106337 K981601 000
10803622106344 K981601 000
10803622106351 K981601 000
10803622106368 K981601 000
10803622106375 K981601 000
10803622106382 K981601 000
10803622106399 K981601 000
10803622106405 K981601 000
10803622106412 K981601 000
10803622106429 K981601 000
10803622106436 K981601 000
10803622106443 K981601 000
10803622106450 K981601 000
10803622106467 K981601 000
10803622106474 K981601 000
10803622106481 K981601 000
10803622106320 K981601 000

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