COAGULATION CONTROL LEVEL 2 (ABNORMAL)

Control, Plasma, Abnormal

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Coagulation Control Level 2 (abnormal).

Pre-market Notification Details

Device IDK984130
510k NumberK984130
Device Name:COAGULATION CONTROL LEVEL 2 (ABNORMAL)
ClassificationControl, Plasma, Abnormal
Applicant PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville,  NC  28078 -8144
ContactMark Ellis
CorrespondentMark Ellis
PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville,  NC  28078 -8144
Product CodeGGC  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-18
Decision Date1998-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275000566 K984130 000

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